Powered exoskeletons in 2026: personal and clinic models, Medicare's K1007 brace code, and what 56 FDA reports show

Before the next session: five checks

Already training in an exoskeleton, or about to start? Check these first. Choosing one? Start at the short answer below.

• Swelling, warmth, bruising or a change in shape of a knee, ankle, foot or hip in the hours or days after a session. In the FDA reports we read, many fractures were found this way, some in users who could not feel the injury. Stop using the device and call the clinician the same day.
• The fit was changed: segment lengths, footplates, straps or the knee brackets. ReWalk's first FDA review warns that "Improper adjustment of device size to suit the user could cause skeletal fractures and injury to the patient." Ask who checked the fit, and check the skin and joints after the next session.
• Your trained companion is beside you, close enough to catch you. ReWalk's US indication requires a specially certified companion, and Wandercraft says Eve users train with a companion before taking it home; ask what your model's labeling says.
• The battery pack is charged exactly as the manual says, with the maker's charger. Two FDA reports describe a waistpack that caught fire while charging at home, one after about 48 hours on charge and one after about 6 hours.
• You know how to get out of the device fast if you feel faint, have pain or the device stops. Practise it with the trainer, not on the day you need it.

These five come from the documents and reports this guide is built on, plus common-sense precautions. Everything else in it can wait for the next appointment with your clinic.

The short answer

A powered exoskeleton is a wearable frame with motors at the hips and knees, and in some models the ankles, that lets a person with paralysis or weakness in the legs stand up, walk and sit down again. The FDA classes it as a prescription device. There are two kinds. Personal exoskeletons, such as the ReWalk 7, the Ekso Indego Personal and the new Wandercraft Eve, are fitted to one person and used at home and in the community after training; ReWalk's US indication requires a certified companion, and Wandercraft says Eve users train with one. Clinic exoskeletons, such as the EksoNR and the Atalante X, stay in rehabilitation centres and are run by trained therapists.

Since 1 January 2024, Medicare treats a personal exoskeleton as a brace, billed under code K1007. Lifeward, the maker of ReWalk, said in April 2024 that Medicare's fee schedule set a lump-sum purchase amount of $91,032 for each state. None of these makers publishes a price on its product page, and our catalog lists none for its walking exoskeletons.

Who may use one is a clinician's decision, made after an assessment and a trial. This guide explains what the makers and the FDA documents say, what Medicare pays, and what 56 FDA reports on exoskeletons show goes wrong. The short version of the reports: the most common story is an injury found after a session, often swelling that turned out to be a broken bone (by a word search, 16 of the 56 reports mention both swelling and a fracture), and most reports came from clinics, where a therapist was present.

Mobility Atlas earns a fee or margin when you order through us; this guide uses only the makers' and regulators' published documents, FDA reports and our own catalog. Exoskeletons are prescribed, fitted and trained through clinics and the makers' own teams, so the first step is an evaluation, not an order. If you want help finding a clinic or a model named here, send an enquiry and ask us to find it.

Personal or clinic: two kinds of exoskeleton

The difference matters for everything that follows. A personal device is yours to use most days, so the fit, the companion, the charging and the surfaces at home are your responsibility. A clinic device is used for a session under supervision, so the questions are about the clinic: who runs the session, how the fit is checked, and what happens if something hurts.

Which exoskeleton, for whom

Which powered exoskeletons can you get in 2026, and who are they for? Mobility Atlas read the FDA records and the makers' pages in October 2026. Three personal exoskeletons are sold in the US for home and community use: Lifeward's ReWalk 7, for spinal cord injury at T7 to L5 with a certified companion, the only one its maker says handles stairs and curbs; the Ekso Indego Personal, for injury levels T3 to L5; and Wandercraft's Eve, a self-balancing, hands-free device for adults with spinal cord injury at any level who can safely operate the controller and have no contraindications listed in the user manual. Clinic devices such as the EksoNR, which Ekso says is cleared for stroke, brain injury, MS and spinal cord injury, and the Atalante X, for stroke, spinal cord injury and MS, stay in rehabilitation centres. All are prescription devices under FDA product code PHL. A physician and a therapist decide who is a candidate, after an assessment and a trial.

The personal exoskeletons sold in the US in 2026

Three personal exoskeletons are on sale in the US as of October 2026, each with its own US indication for use. The table uses the makers' own pages and our catalog.

Lifeward describes the ReWalk 7 as "The only personal exoskeleton that enables access to environments with stairs and curbs," and its US indication says it is intended for "ascending and descending stairs and curbs." Ekso's page says the Indego Personal "is not intended for sports or stair climbing" and that its modular design "allows you to put on and take off the device without assistance." Wandercraft's launch release says Eve "is designed to complement, not replace, a wheelchair."

Our catalog records Eve's FDA clearance number as K260381 and lists a maximum user of 100 kg and 1.94 m with a 4 h battery, as the maker states them. Lifeward's product page publishes no weight limit, battery time or device weight for the ReWalk 7, so ask for the current user manual.

Wandercraft's site says Ekso Bionics has joined Wandercraft; we name each maker as its product pages do.

Clinic exoskeletons: EksoNR, Atalante X and others

Clinic exoskeletons are bought by hospitals and rehabilitation centres. You use one as part of therapy, and the clinic decides who can try it.

• EksoNR. Ekso calls it "the first exoskeleton FDA-cleared for stroke, acquired brain injury, MS and SCI." Its page says it "fits patients under 220 pounds and between 5′ and 6’4″," weighs "approximately 55 lbs with batteries," carries its own weight, and is "FDA cleared for use for those who are 18 years old and over."
• Atalante X. Wandercraft's page says it uses "self-balancing technology" so that patients "without trunk control" can walk, hands-free, with 12 motors including an articulated ankle. In the US it is indicated for hemiplegia after a stroke, spinal cord injury C4 to L5, or multiple sclerosis, for adults "able to tolerate standing." The page says it "is not a personal device for home use."
• Others in our catalog. Cyberdyne's Medical HAL lower limb types are, as our catalog notes, supplied to facilities, not rented to individuals. Fourier's ExoMotus M4, ABLE Human Motion's ABLE Exoskeleton and others are clinic devices made in China and Spain, as our catalog records.

Ask the clinic which device it has, which conditions it is cleared for, and how many sessions a course usually takes there. A clinic course can be a way to try an exoskeleton before anyone talks about a personal one.

What the FDA rule requires

Every FDA-cleared powered leg exoskeleton named in this guide, from ReWalk to Eve, sits under one federal rule, 21 CFR 890.3480, product code PHL. Some devices in our catalog are registered differently in the US, such as the Agilik, which our catalog records as a Class 1 device, or are not cleared by the FDA at all. The rule says a powered lower extremity exoskeleton "is a prescription device that is composed of an external, powered, motorized orthosis that is placed over a person's paralyzed or weakened limbs for medical purposes." It is Class II, with special controls. openFDA's classification record lists 26 submissions under PHL, from ReWalk's De Novo in 2014 to Eve's clearance, K260381.

The special controls tell you what the FDA expects a maker to prove and to give you. Clinical testing must consider the "Level of supervision necessary" and the environment of use, "indoors and/or outdoors." A training program must be included so that "the clinician, user, and companion can" identify safe places to use the device, use all its safety features, and operate it in real conditions. The labeling must include "warning against activities and environments that may put the user at greater risk," instructions on fitting, and a summary of the adverse events seen in the clinical studies.

In plain words: the training, the companion and the list of places you may walk are part of the clearance, not extras. Ask to see the labeling for your model, including the summary of adverse events from its studies.

What the labeling must tell you

The FDA rule lists what the labeling for the physician and the user must contain, so you can ask for each part by name. It must give "Instructions on fitting the patient," instructions on every program, control, mode and safety feature, and "Instructions for properly maintaining the device." It must also give "Information on the patient population for which the device has been demonstrated to have a reasonable assurance of safety and effectiveness," battery and other test information, and a summary of the clinical studies, including "Adverse events encountered under use conditions" and the level of supervision and the places in which the device was studied.

• Ask for the user manual and the clinician manual of the exact model and software version you will use.
• Read the section on who the device was studied in, and compare it with your own situation.
• Read the adverse events from the clinical studies, and ask the clinician what they mean for you.
• Keep the maintenance schedule where your companion can find it.

Lifeward's investigation reports from 2025 in our set say it was updating its user and therapist manuals with additional warnings, so ask whether your copy is the current one.

What the makers' own studies and figures say

Makers cite studies on their pages; the claims are theirs. Wandercraft's Eve release describes a study at Kessler Foundation and the James J. Peters VA Medical Center: among "the first 16 participants who completed the protocol," all reached the study's goals for two walking tests, 15 reached the donning goal after four training sessions, and "The researchers reported no serious adverse events among the participants who completed the protocol." Wandercraft's Atalante X page cites one study of people after a stroke with a mean donning time of 6 minutes 43 seconds and doffing of 1 minute 32 seconds. Ekso says the EksoNR is "backed by more than 200 published articles."

Ask the clinician which studies included people like you, how many people dropped out, and what harms were recorded. A study's goals for walking tests are not the same as the goals you set with your therapist.

ReWalk's first clearance in 2014, read closely

The FDA granted ReWalk's De Novo request, DEN130034, on 26 June 2014, creating the product code PHL. The indications then were narrower than today's: individuals with spinal cord injury at T7 to L5 "with supervision of a specially trained companion," and T4 to T6 "in rehabilitation institutions." The FDA's review says "The ReWalk is not intended for sports or stair climbing." The ReWalk 7 page's current US indications now include stairs and curbs.

The review is worth reading because it shows what the FDA looked at first. Its list of candidate characteristics includes hands and shoulders that "can support crutches or a walker," "Healthy bone density," being "Able to stand using a device such as a standing frame," being "In general good health," a height between 160 cm and 190 cm and a weight that "does not exceed 100 kg (220 lbs)." Its warnings include: "Users must be trained to use the ReWalk," "Use the device on paved surfaces on dry, even surfaces," and "The device must be fitted over clothing to prevent skin abrasions."

Those limits were for the 2014 device. Newer models have their own indications and limits, so ask for the current labeling of the exact model you are offered.

Who can use one: what the documents list

Eligibility is a clinician's decision. The documents show what clinicians look at, and they differ by model.

Bring the questions in this table to the assessment. If the answer for you is no on one point, ask what would change it and whether a clinic device might suit you in the meantime. A physician, a physical therapist and the maker's trainer each have a part in the decision, and none of it can be settled by reading a web page.

Does Medicare pay for an exoskeleton?

Does Medicare pay for a personal exoskeleton? Mobility Atlas read the Medicare coding notice, the makers' coverage pages and Lifeward's fee announcement in October 2026. Since 1 January 2024, a CMS rule treats powered exoskeletons that support weak arms or legs as braces, and personal leg exoskeletons are billed under code K1007, a powered hip, knee, ankle and foot device with all its parts included. The device must be custom fitted, and since 1 June 2024 only products that have passed a coding review and are on the PDAC contractor's list may be billed under K1007. Lifeward says Medicare's 2024 fee schedule set a lump-sum purchase amount of $91,032 for each state. Ekso and Wandercraft say Medicare may cover qualifying personal exoskeletons, including theirs, subject to coverage requirements. Coverage is decided case by case: Lifeward's page says the ReWalk is covered "where reasonable and necessary," based on the medical record. Confirm with the supplier and your plan before you start the paperwork.

Medicare: the brace category and code K1007

The Medicare contractors explained the change in a joint notice of 28 December 2023. CMS published final rule CMS-1780-F on 13 November 2023, effective 1 January 2024, which writes the Medicare definition of a brace into 42 CFR 410.2. The notice says the rule "finalizes that powered exoskeleton devices that support a patient's weak arms or legs are classified as braces."

Code K1007 covers a "BILATERAL HIP, KNEE, ANKLE, FOOT DEVICE, POWERED," with "all components and accessories, motors, microprocessors, sensors." The notice says "There are no additional add-on codes," and that the device "is custom fitted per the DMEPOS Quality Standards, Appendix C." For claims from 1 June 2024, only products that "have received mandatory code verification review" and appear on the PDAC Product Classification List may be billed under it. In December 2023, the notice said, one product was coded K1007: the ReWalk.

Since then, Ekso says it has "finalized a reimbursement rate" with CMS for the Indego Personal, and Wandercraft's launch release says Medicare covers qualifying personal exoskeletons "as custom-fitted orthoses under HCPCS billing code K1007." Those are the makers' statements. Ask the supplier whether your model is on the PDAC list, and get the answer in writing.

What you pay out of pocket depends on your Medicare plan and on whether the supplier accepts Medicare's amount. If you have a Medicare Advantage plan, ask the plan how it covers code K1007. Ask the supplier for a written estimate before the fitting.

What an exoskeleton costs

No maker of the medical walking exoskeletons in this guide publishes a price. Lifeward's ReWalk page, Ekso's Indego Personal page and Wandercraft's Atalante X page show none, and our catalog lists no price for any of its 23 walking exoskeletons, checked October 2026. The prices our catalog does list in its wider exoskeleton section are for single-joint and soft wearables and hand orthoses, such as the Dnsys X1 at USD 689 on the maker's site, which are a different kind of device.

The one public figure is Medicare's. Lifeward's press release of 12 April 2024 says CMS revised its April 2024 fee schedule to include "a final lump-sum Medicare purchase fee schedule amount for personal exoskeletons with a ceiling-to-floor range from $109,238 to $81,929, and an established rate of $91,032 for each state." It says the rate applies to claims with dates of service on or after 1 April 2024, and that CMS set it through a "gap filling" process by averaging pricing information from Lifeward and other makers. We did not read the CMS fee schedule file itself, so treat these figures as Lifeward's report of it, and ask the supplier what applies in 2026.

The Medicare amount is a purchase price for the device with its parts. Ask separately about training sessions, the companion's training, servicing, spare batteries, crutches and travel to the clinic, and who pays for each.

The VA, workers' compensation and paying yourself

The makers describe other routes, and each statement here is theirs. Lifeward's veterans page says it "has worked with the VA to establish a policy that ensures medically eligible Veterans have access to personal exoskeleton technology, regardless of whether or not their spinal cord injury is service-related." Ekso's page says "A VA policy allows Ekso Indego Personal to be issued to qualified veterans" and lists "Medicare, VA benefits, & workers’ compensation." Wandercraft says personal exoskeletons are covered by Medicare, the VA through its distributor USVetServ, and workers' compensation, "subject to applicable requirements," and that financing is available to people who pay themselves.

Rules for private insurers, Medicaid and health systems outside the US differ by plan and country. Ask the maker's reimbursement team which payers have covered the device in your state or country, and confirm with your own payer before the evaluation.

From evaluation to delivery: the steps

Wandercraft's launch release spells out the steps for Eve. Ask the maker of any other device whether its steps differ.

1. A clinical evaluation and a trial session in the device.
2. A physician's order, if the trial goes well.
3. Fitting: the device is "individually fitted and manufactured," Wandercraft says, and Medicare's coding notice requires custom fitting.
4. Training for the user and the companion with the maker's team, before the device goes home.
5. Delivery, with "ongoing support afterward," Wandercraft says.

Lifeward's veterans page says a local Lifeward representative can help identify an "Exoskeleton-Certified VA Hub, Spoke or Community Care Network provider close to home." Wandercraft says National Seating & Mobility will support evaluation and delivery of Eve "through a network of more than 180 locations." Ask how far the nearest certified clinic is, because training means many visits.

The trial session is also where many problems in the FDA reports begin. Ask how the clinic checks the fit before the first stand, how long the first session lasts, and how it checks the skin and joints afterwards.

The companion: who walks beside you

ReWalk's US indication requires "supervision of a specially certified companion." Wandercraft says Eve users "complete a clinical evaluation and training program with a companion before taking Eve home." The FDA rule requires a training program for "the clinician, user, and companion." Ekso's page, by contrast, says the Indego Personal "enables patients with mobility impairments the opportunity to walk independently," and does not mention a companion; ask what its labeling says.

The companion may be a family member, a carer or a therapist who has completed the maker's course. Their job is to stand close, help with sitting down and standing up, and catch a loss of balance. One FDA report on a fall at home says a maker concluded that the companion "should have been standing closely behind the user to support him as recommended in the user manual." Another says "every ReWalk user, no matter how skilled, should have a trained ReWalk companion assist him during use," in the maker's words after a user tried to walk alone and fell.

• Who will be your companion on weekdays, weekends and holidays?
• Has a second person done the course, for the days the first cannot come?
• Does the companion know the fast-exit steps and the low-battery signal?

Stairs, curbs, slopes and surfaces

Where you may walk depends on the model and its labeling. The ReWalk 7's US indication covers "standing and walking on level surfaces and mild slopes, and ascending and descending stairs and curbs." The Indego Personal is "not intended for sports or stair climbing," and Ekso says it can be used on "carpets, floor, grass, and asphalt." The Atalante X is "not intended for sports activities or stair climbing."

ReWalk's 2014 FDA review warned that "Using the device on irregular surface could result in loss of balance and possible injury," and told users not to walk "on sand, in stony areas, or on any surface that isnt appropriate for crutches." It also said "Do not use the device on a non ADA compliant ramp."

At home, walk the route with the trainer before you use it alone with your companion: rugs, thresholds, wet floors, leaves brought in on shoes, and tight turns around furniture. One fall report in our set began with a crutch on a wet leaf indoors; another with a turn around a table. If you are also thinking about stairs in a wheelchair, the Mobility Atlas guide to stair-climbing wheelchairs covers that separately.

Batteries and charging

ReWalk's 2014 FDA review describes a lithium ion battery "capable of allowing a user to walk continuously for more than 2 hours on a charge," with two redundant battery systems. It says the user is warned of a low battery "by a short vibration (buzz) repeated every 10 seconds," and that a low battery has about 15 minutes of life left. Lifeward says the ReWalk 7 has "extended battery life" but publishes no figure; Wandercraft says the Atalante X runs all day "with a battery change," and our catalog lists 4 h for Eve.

• Learn the low-battery signal for your model, and what the device does when the battery runs flat.
• Charge with the charger the maker supplies, for the time the manual gives.
• As a general precaution, not a rule from the documents, charge on a hard, clear surface away from anything that burns, where you can see the pack.
• If the pack smells hot, smokes or swells, unplug it if safe, move away, and call the maker.

Two FDA reports describe ReWalk waistpacks, where the lithium ion packs sit, that caught fire while charging at home, one after about 48 hours on charge and one after about 6 hours, and one recall covers the same problem. Nobody was hurt. The study section below gives the details.

Fit, footplates and straps

Exoskeletons are adjusted to the user's leg lengths, pelvis width and foot size, and the straps and brackets press on the shins, knees and pelvis. The FDA reports show how much depends on that fit: a footplate too small, a segment shortened, a knee bracket rotated, a left leg length that a therapist found set a few notches off. The ReWalk 7 page says "The system is configured for each individual, ensuring a precise fit."

• Ask the trainer to show you the settings for your device, and write them down.
• After any change of shoes, weight, spasticity or medication, ask for the fit to be checked again.
• If the device feels different, a hip feels higher, or a joint feels pinched, stop and say so.
• Wear the clothes and shoes the trainer recommends; the 2014 review says the device "must be fitted over clothing to prevent skin abrasions."

Skin and joints after every session

Many users of exoskeletons have reduced or no feeling in their legs, so pain is not a reliable warning. A report in our set says, after a broken ankle, "because the user has a complete spinal cord injury he obviously did not feel the moment of the fracture." Clinics in the reports describe a skin and joint check after each session, and the reports show why: swelling, redness, a C-shaped bruise on the heel from a footplate's heel cup, or a hot knee were often the first sign.

1. Take off the device and look at the skin under every strap, bracket and footplate.
2. Compare both knees, both ankles and both feet for swelling, warmth, colour and shape.
3. Look again that evening and the next morning, or ask someone to.
4. Call the clinician the same day about any new swelling, warmth or bruise, and do not use the device until it is checked.

What the clinician then does, an X-ray or a scan or a wait, is their decision. Your part is to notice early and say so.

Bones and the trial session

ReWalk's 2014 FDA review lists "Healthy bone density" among the characteristics of candidates, and warns that a badly sized device "could cause skeletal fractures." Several reports in our set describe later checks: Lifeward's investigations included "bone density results" reviewed by an outside physician, and one report from France describes bone tests after a session that showed severe osteoporosis.

We do not give medical advice about bones. Ask the physician whether a bone check is part of the assessment for you, what the result means for standing and walking, and how the first sessions will build up. Ask the trainer how the device handles a spasm during sit-to-stand: in one report, Lifeward named "the sudden left lower extremity spasm occurring during the sit-to-stand transition" as the probable cause of a fracture at the knee.

An exoskeleton and a wheelchair

None of the makers presents an exoskeleton as a replacement for a wheelchair. Wandercraft says Eve "is designed to complement, not replace, a wheelchair, offering another mobility option for moments when users choose to be upright." Ekso says the Indego's "lightweight and narrow design allows Ekso Indego to be worn while seated in most wheelchairs."

So the wheelchair still has to be right, and the transfer in and out of the device matters. Ask the therapist how you will get into the device from your chair, whether you need a lift, and how the chair's seat height suits it. The Mobility Atlas guides to electric wheelchairs, lightweight wheelchairs and patient lifts cover the chair and the transfer.

Children and smaller users

Most adult exoskeletons are not for children. EksoNR and Atalante X are for adults 18 and over. Our catalog lists several devices made for children, mostly used in clinics:

• Trexo Theo (Canada): four adjustable sizes, users up to 150 lb, FDA 510(k) cleared (K254198) and a prescription device in the US.
• Marsi Bionics ATLAS 2030 (Spain): 8 active joints, adjustable for growth. Marsi also lists a pediatric EXPLORER; we could not confirm its age range on the maker's page.
• Cyberdyne HAL-ML07 (Japan): a pediatric lower limb type with FDA 510(k) clearance, supplied to facilities only.
• ExoAtlet Bambini (Luxembourg): eight actuators, for users 115 to 150 cm.
• Agilik (Canada; listed under Agilik Technologies): a powered knee device of 2.2 kg for both legs, users under 70 kg, over age 5, per a third-party listing.

Ask the child's physical therapist which of these, if any, a local clinic uses, and what the child's own therapy goals are. These rows come from our catalog, checked October 2026.

Other exoskeletons in our catalog

Our catalog has 23 walking exoskeletons. Beyond the models above, it lists these, among others, with the specifications we could confirm on each maker's page or listing:

Clearances differ by country. A device with a CE mark in Europe may not be cleared by the FDA, and the reverse. Ask the maker or the clinic which clearance covers the use you are offered, in your country.

How Mobility Atlas read 56 FDA exoskeleton reports

The FDA collects reports about medical devices in a database called MAUDE. Makers, importers and user facilities such as hospitals are "mandatory reporters"; patients, families and clinicians can report voluntarily. Powered exoskeletons are filed under product code PHL. On 18 October 2026 we read every report with a description filed under PHL in openFDA, together with reports on powered arms, stair-climbing wheelchairs and all-terrain chairs for two other guides: 161 reports in all. 56 of them describe a powered exoskeleton, received from March 2015 to September 2026, and those are the reports this guide counts.

Before coding, we wrote a codebook: the device, what went wrong first (fall with a device fault, battery, control or sensor, motor, structure, skin or fit, use or training with no fault alleged, a problem not described, or no device problem described), flags for injury and fall, the setting (home, clinic or unclear) and what the maker found. The codebook was fingerprinted with a time stamp before coding began.

Two independent coders then read all 161 reports separately, without seeing each other's answers. The coders were AI language models working separately; the method page says exactly how. They agreed on the device in 99.4 percent of reports (kappa 0.990), on what went wrong in 88.8 percent (kappa 0.859), on the setting in 90.1 percent (kappa 0.843) and on what the maker found in 97.5 percent (kappa 0.954); kappa is a standard measure of agreement beyond chance. We settled the 40 reports where they differed under eleven written rules, then ran a consistency pass that changed 18 more agreed codes to follow the same rules, and counted the results by script. Where we give a count from a word search, it runs over the description of the event, not over the maker's later follow-up notes. One pair of reports in the 56 has identical text, and a few others describe the same event twice; we say so where it matters.

What the reports show: the big picture

What goes wrong with powered exoskeletons, according to FDA reports? Mobility Atlas had two independent AI coders read all 56 exoskeleton reports with a description filed under FDA product code PHL, as of October 2026. 50 describe an injury and 5 a fall, and none was filed as a death. By a word search, 28 mention a fracture. A story repeats: a session ends without incident, and hours or days later the user finds swelling in a knee, ankle or foot; 16 reports mention both swelling and a fracture. In 26 reports no device problem is described at all, and 12 more describe a fall or an injury during use or training with no device fault alleged. Fit problems, cracked parts, a hesitating device and two battery fires make up most of the rest. 38 reports came from clinics or training sessions, where a therapist or trainer was present, 7 from home or community use, and 11 do not say. Counts are reports, not rates.

By event type, the reporters filed 49 as injuries and 7 as malfunctions. The word search counts mentions, not confirmed fractures: three reports mention the word only to say there was no fracture, and six that describe a broken bone in other words ("broken leg", "broke his tibia", "FX" in one report) are not caught by it.

What these reports cannot tell you

The FDA says report data are not meant "to evaluate rates of adverse events," or to compare devices, and that a report "does not necessarily demonstrate that the device caused or contributed to the adverse outcome or event." Nobody knows from these reports how many sessions or steps were taken in total, or how many people use each model. A maker with more users, or one that files every complaint, will have more reports.

The reports also lean towards the clinic. 38 of the 56 came from clinic, rehabilitation or trial sessions, where a therapist or trainer was there to notice swelling and file a report. Problems at home may be reported less often, or not at all. Read the counts as a list of what has been reported, and of what to watch for, not as a measure of how safe one exoskeleton is against another.

Fractures found after the session

The commonest story in the reports is short. A session goes well; later that day or in the following days the user notices swelling; an X-ray or a scan shows a fracture. By a word search, 27 reports mention swelling, and 16 of those also mention a fracture. 21 mention a knee, 15 the tibia or shin bone, and 14 a heel or foot.

The wording repeats from report to report. One says the user "had a swollen ankle after the last ReWalk training." Another says "after training on the ReWalk device the user noticed that her left knee was swollen, an X-ray imaging test identified a tibial plateau fracture." A 2026 report says the user "reported a diagnosis of fractures/cracks in both heels and ankle joints" after a test session in which, the report says, no unusual events were seen; the maker's follow-up says the medical records confirm right hindfoot fractures but not the reported injury on both sides.

In an Atalante X report from France, a patient felt unwell with a drop in blood pressure and was taken out of the device by its emergency extraction procedure; the next day the patient contacted their physician, and an X-ray and CT scan found two fractures, and the report says "the patient's foot may have been briefly trapped" during the extraction. Two reports say the user, with a complete injury, could not feel it. A research team's report on a study session states that "lower extremity fractures still remain a risk for persons with quadriplegia/paraplegia that use a robotic gait training device," despite evaluation and adjustments. This is why the after-session check at the top of this guide matters more than any feature of the device.

Fit and alignment

Six reports put the harm down to how the device sat on the body, and all six describe an injury. In one, a therapist "feels the fracture may have occurred after adjustments were made to shorten the length of both the upper and lower segments" of the device. In another, the maker's follow-up says the clinic was "using a smaller footplate than was appropriate" and a heel fracture followed. In a 2024 trial session report, "the patient was misaligned with the device" and the front knee bracket had rotated downward; Lifeward's investigation found no malfunction but said it was updating its user and therapist manuals and training "with additional warnings."

Two more describe an ankle that rolled inside the foot strap of an Ekso, filed once by the hospital and once by the maker. The hospital report says "the patient's dorsiflexion was overestimated and perhaps, additional necessary adjustments to the Ekso were not made."

Fit is set by the clinic and the maker's trainer, not by the user. What you can do is ask what was changed before each session, and check the skin and joints afterwards.

Falls

Five reports describe a fall, and four of them were in home or community use with a ReWalk. One user "slipped on a leaf that was brought into his house by a visitor and broke his arm," and the maker concluded the companion was not close behind as the manual recommends. One "fell for unexplainable reasons" while walking around a table at home with a physiotherapist. One "lost balance and fell backwards" and hit their head while trying to walk alone, the report says. In the fourth, both user and companion said the system "began to fold down," described as a "graceful collapse," and the user was found to have a fracture; it is the only report in the set coded as a fall with a device fault alleged.

The fifth fall was in a clinic in France: during a therapist training session, the Atalante X was attached to its overhead rail with "a thin metal cable intended solely to prevent the swivel retaining screws from loosening," the report says, instead of the load-bearing hook, and the exoskeleton fell sideways. No one was hurt.

In another clinic report, an Atalante X lost lateral balance at the end of a session while the therapist stepped away and an assistant let go of the mobile patient lift it was attached to; staff caught it and were bruised. The report names a patient above the device's weight limit, a high-friction floor and chairs in the way, and says Wandercraft began a field correction for use with mobile lifts.

Parts that cracked or came loose

Four reports describe a part that cracked, broke or came loose, or a crack heard at a joint, and one more only "a couple of loud cracks" heard during training, the report says. On a ReWalk in gait training, "the pelvic band cracked and disengaged from the device." On another, "the left hand (LH) front knee bracket (FKB) cracked and the device returned to sit position," and the user was found to have a broken leg. A third describes "an audible crack (plastic)" at the hip during the first stand of a training session.

The fourth is the only report in the set where the maker confirmed a fault. On an Indego in clinic training, a cover separated and lateral stability fell; the returned device had cracked screw bosses at the hip, and "4 upper leg cover screws were missing," which the maker's report says were not installed during assembly. No one fell or was hurt.

Devices that hesitated or got stuck

Four reports, all on Ekso devices in clinics, describe a device that behaved unexpectedly. Therapists reported that an Ekso "hesitated" during sit-to-stand, that a user was "getting stuck in the transition from sit to stand," and in another that standing was hard to complete. In a research study, a user said they "did feel a buckle during gait training" just before the end of the session; a later scan found a fracture.

All four describe an injury, mostly swelling or a fracture found afterwards. In one, Ekso said the sit-to-stand problem was "likely clinical in nature," with causes such as poor weight shift and a sling not fully tightened. If a device hesitates or a hip feels higher than the other, stop, sit down, and ask for the fit to be checked before going on.

Battery fires while charging

Two reports describe a ReWalk waistpack, where the lithium ion battery packs sit, that "caught fire while it was being charged" at the user's home: one after about 48 hours on charge, the other after about 6 hours, according to the reports. Nobody was using the device, which cannot be powered on while charging, and nobody was hurt; both reports mention minor damage to the floor. Both were filed in 2021, and each says "we realized this event should have been reported" after a review.

The FDA recall file has a matching record, Z-1553-2021, covering 350 units of the ReWalk Personal 6.0, Personal 5.0 and ReWalk R Systems. Its reason reads that ReWalk "received two complaints (one in the US; one in the Germany)" that the waistpack "caught fire while being charged." The recall is listed as terminated. Neither the reports nor the recall record give a cause tied to charging time. Follow the charging rules in your manual.

Reports the maker or sponsor puts down to other causes

Some reports describe harm that the maker or a study sponsor puts down to something other than the device. Three reports describe one heart event during a supervised exercise session with a Keeogo device in a French study: the device was "confirmed to be functioning properly," the report says, though the investigator noted that "the physical effort required while using the device during exercise may have contributed to the event." A follow-up report says the investigator rated the link to the device as probable, while the sponsor rated it as unrelated. Others describe blood clots in a leg found after sessions, a knee injury the user first linked to a car transfer before the device was delivered, though the user's physician would not rule out the device, and a partial forefoot amputation that Lifeward's outside physician put down to vascular disease.

These reports are a reminder that standing and walking in an exoskeleton is physical effort. The assessment before a trial, and any medical clearance, are for the physician to decide.

Clinic, home and unclear

All 7 home or community reports name a ReWalk. Four are the falls described above, two are the battery fires, and one is a knee injury the maker concluded was not related to the device. The clinic reports cover every maker: all 7 Ekso reports, all 4 Wandercraft, all 3 Indego and all 3 Keeogo, and 21 of the 39 ReWalk.

A personal exoskeleton moves the setting from the clinic to the home, and with it the person who checks the skin, notices swelling and decides to stop. At home that is you and your companion.

What the makers found

In 24 reports, the maker, the clinic or the study team examined the device or its logs and found no fault, or named another cause: a slip on a wet leaf, a companion not close enough, a user walking alone, a patient above the weight limit, a wrongly attached cable, a spasm, weak bones or a medical condition. In 31 reports nothing was evaluated or no conclusion was given. In one, the Indego with missing screws, the maker confirmed a fault.

A finding of no malfunction does not mean nothing went wrong. Three Lifeward follow-ups from 2025 find no device fault and then describe updates to manuals and training "with additional warnings," the reports say. The reports show a device, a body, a fit and a session working together, and fractures that can follow when one of them is off.

Who files the reports, and when

ReWalk dominates the reports, and 2018 stands out: 19 of the 21 reports that year name ReWalk, several of them citing the same root cause analysis and the 2017 ReWalk Personal 6.0 recall. Since 2024, the 14 reports name ReWalk (7), Wandercraft (4) and Keeogo (3). Report counts depend on how many devices each maker has in use and how it files, and the reports show neither; they say nothing about which exoskeleton is safer.

Some reports also arrived late, the reports themselves say. Two Indego reports from 2020 say they were "submitted late due to a loss of access to WebTrader," their electronic filing account. A 2022 Ekso report says an earlier form "was not successfully submitted to FDA" and was being filed retroactively. A 2024 Wandercraft report says the maker was "still in the enrollment process for electronic submission." The two ReWalk battery fires were filed in 2021 after a review. Late or missing filings are one more reason the counts by year are a record of reporting, not of risk.

The recall file

The FDA recall file holds three records under PHL. In August 2017, Argo Medical Technologies, ReWalk's maker, recalled 127 ReWalk Personal 6.0 units after it "received complaints for ReWalk Personal 6.0 of an injury to tibia and fibula," the record says (Z-0944-2018, terminated). The battery recall of 2020 (Z-1553-2021, 350 units, terminated) is described above.

The newest, Z-1739-2025 from April 2025, covers 3 Atalante X units for "Potential for exoskeleton to lose lateral balance and cause patient to fall," and was open when we read it. The record describes the Atalante X as intended for use "in rehabilitation institutions under the supervision of a trained operator." Ask the clinic or the maker whether any correction applies to your device, and look up the model in the FDA recall database.

Mistakes the reports repeat

• Walking without the trained companion close behind, where the labeling requires one (two ReWalk fall reports).
• Changing segment lengths, footplates or brackets and going on without a careful check of the fit.
• Treating a quiet session as a safe one, and missing swelling the next day.
• Carrying on after a device hesitates, buckles or feels uneven.
• Charging a battery pack outside the manual's instructions.
• Using a device outside its limits: weight, surfaces, stairs, or a clinic device's attachment and lift rules.

A session checklist

When to report a problem to the FDA

In the US, anyone can report a problem with a medical device to the FDA through MedWatch. Outside the US, report to your country's medical device regulator as well as to the maker. A recall announcement posted on the FDA's website gives the routes: "Online: By completing and submitting the report online at https://www.accessdata.fda.gov/scripts/medwatch," or by a form you mail or fax; you can call 800-332-1088 to request one. Report injuries, falls, a device that hesitated or moved unexpectedly, a part that cracked, and any battery that overheated or burned. Tell the clinic and the maker too; makers are mandatory reporters.

Keep the device and any broken part, note the model and serial number, the settings, what happened and when you first noticed any swelling, and keep copies of X-ray reports.

Three composite scenarios

These are composite scenarios, not individual customers. Each one combines facts and ranges already given in this guide to show how the decision plays out.

Scenario one: a Medicare beneficiary with a spinal cord injury at T10 asks about a personal exoskeleton. The clinic runs an assessment and a trial in a ReWalk 7, the physician writes an order, and the supplier confirms in writing that the model is on the PDAC list for K1007 before the fitting. The user's partner completes the companion course.

Scenario two: after a good third training session, a user's left knee is swollen the next morning. They stop, photograph it and call the clinician, who arranges an X-ray. The clinic reviews the fit before any more sessions.

Scenario three: a family is unsure how long the battery pack should stay on charge. They read the charging section of the manual, follow its instructions from then on, and ask the maker's service team if anything is unclear.

Questions to ask the clinic and the maker

• Which exoskeletons does this clinic have, and which conditions and levels are they cleared for?
• What does the assessment include, and will it look at bone health?
• How is the fit checked before the first stand, and after every change?
• How are skin and joints checked after each session, and who do I call about swelling?
• Is this model on the PDAC list for K1007, and what will I pay?
• What does the companion course involve, and can a second companion train?
• Where may I walk in it: stairs, curbs, slopes, grass?
• How do I charge the battery, and what does the low-battery signal mean?
• Is this model under any recall or field correction?

Who can use an exoskeleton, and how training builds up, is decided by the physician, the physical therapist and the maker's certified trainer together. Bring these questions to them.

Your plan: 10 minutes, today, this week

In 10 minutes: look at both knees, ankles and feet for swelling, warmth or bruising, and write down your device's fit settings if you have them.

Today: check where and how the battery pack charges, and and, if your model uses a companion, confirm they know the fast-exit steps.

This week: ask your clinic the questions above, and look up your model in the FDA recall database.

Sources and documents

Reports: every FDA MAUDE device report with a description under product code PHL, received from March 2015 to September 2026, read through openFDA on 18 October 2026. Recalls: the three FDA recall records under PHL. Rules: 21 CFR 890.3480, the openFDA classification record for PHL, and the FDA's 2014 De Novo record and review for ReWalk (DEN130034). Funding: the Medicare contractors' joint notice on coding powered exoskeletons under K1007, and Lifeward's April 2024 press release on the Medicare fee. Makers: Lifeward's ReWalk 7 and veterans pages, Ekso's Indego Personal and EksoNR pages, and Wandercraft's Atalante X page and Eve launch release. Catalog: the 23 walking exoskeleton rows of the Mobility Atlas catalog. Every source is linked in the list at the end of this page.

Related guides on Mobility Atlas: Stair-climbing wheelchairs; Prosthetic legs; Electric wheelchairs; Lightweight wheelchairs; Patient lifts.

Method in brief: we coded the 161 reports in the pool, 56 of them on exoskeletons, using a codebook written and fingerprinted before coding, with two independent coders (agreement on what went wrong 88.8 percent, kappa 0.859), settled the 40 reports where they differed under eleven written rules, ran a consistency pass that changed 18 more, and counted the results by script. The two coders were AI language models working separately, each without access to the other's answers. Quotes from reports are shown in sentence case; the FDA publishes most of them in upper case. The codebook, the rules, the method and the coded table are on the data and method page under CC BY 4.0.

Prices checked October 2026: no maker of the medical walking exoskeletons in this guide publishes a price, and the only figure in this guide is the 2024 Medicare amount as Lifeward reported it; confirm costs with the supplier. Documents checked October 2026: FDA reports, recall and classification records, the federal rule, the FDA review, the Medicare notice and the makers' pages.

Have you trained in an exoskeleton, or lived with one at home? Send us a note through the enquiry form with the model and what happened; we use readers' notes when we update the guide.