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Powered Exoskeleton
FDA product code PHL · Class 2 · Physical Medicine
29
Registered devices
57
Adverse events
3
Recalls
26
510(k) clearances
Devices with this code
HAL for Medical Use — CYBERDYNE, INC.Indego — Ekso Bionics, Inc.HAL for Medical Use — CYBERDYNE, INC.Indego Therapy — Ekso Bionics, Inc.TraumaGuard Intra-abdominal Pressure-Sensing System — SENTINEL MEDICAL TECHNOLOGIESHAL for Medical Use — CYBERDYNE, INC.HAL for Medical Use — CYBERDYNE, INC.Medical HAL Lower Limb Type — CYBERDYNE, INC.HAL for Medical Use — CYBERDYNE, INC.ExoAtlet®-II — COSMO ROBOTICS CO., Ltd.HAL for Medical Use — CYBERDYNE, INC.TraumaGuard Intra-abdominal Pressure-Sensing System — SENTINEL MEDICAL TECHNOLOGIESHAL for Medical Use — CYBERDYNE, INC.ReWalk 7 Personal Exoskeleton Therapist Handheld Device — LIFEWARD LTDReStore — LIFEWARD LTDAtalante X — WANDERCRAFTReWalk(TM) Rehabilitaiton — LIFEWARD LTDEkso — Ekso Bionics, Inc.ReWalk(TM) Personal 6.0 — LIFEWARD LTDKEEOGO - CLINICIAN KIT — B-Temia IncEksoGT — Ekso Bionics, Inc.HAL for Medical Use — CYBERDYNE, INC.Indego — Ekso Bionics, Inc.TraumaGuard Intra-abdominal Pressure-Sensing System — SENTINEL MEDICAL TECHNOLOGIES
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-03 | WANDERCRAFT SAS | Potential for exoskeleton to lose lateral balance and cause patient to fall. |
| 2020-02-28 | Argo Medical Technologies Ltd | ReWalk Robotics received two complaints (one in the US; one in the Germany), which alleged that the ReWalk device waistpack (which is the location of the Li-Ion |
| 2017-08-14 | Argo Medical Technologies Ltd | Firm received complaints for ReWalk Personal 6.0 of an injury to tibia and fibula. |
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