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Powered Exoskeleton
FDA product code PHL · Class 2 · Physical Medicine
28
Registered devices
55
Adverse events
3
Recalls
25
510(k) clearances
Devices with this code
HAL for Medical Use — CYBERDYNE, INC.TraumaGuard Intra-abdominal Pressure-Sensing System — SENTINEL MEDICAL TECHNOLOGIESIndego — Ekso Bionics, Inc.HAL for Medical Use — CYBERDYNE, INC.HAL for Medical Use — CYBERDYNE, INC.ReWalk(TM) Personal — LIFEWARD LTDReWalk 7 Personal Exoskeleton — LIFEWARD LTDReWalk(TM) Personal 6.0 — LIFEWARD LTDExoAtlet®-II — COSMO ROBOTICS CO., Ltd.EksoGT — Ekso Bionics, Inc.KEEOGO - CLINICIAN KIT — B-Temia IncEksoNR — Ekso Bionics, Inc.HAL for Medical Use — CYBERDYNE, INC.Ekso — Ekso Bionics, Inc.ReWalk(TM) Rehabilitaiton — LIFEWARD LTDIndego Therapy — Ekso Bionics, Inc.TraumaGuard Intra-abdominal Pressure-Sensing System — SENTINEL MEDICAL TECHNOLOGIESHAL for Medical Use — CYBERDYNE, INC.Atalante X — WANDERCRAFTReWalk 7 Personal Exoskeleton Therapist Handheld Device — LIFEWARD LTDHAL for Medical Use — CYBERDYNE, INC.TraumaGuard Intra-abdominal Pressure-Sensing System — SENTINEL MEDICAL TECHNOLOGIESHAL for Medical Use — CYBERDYNE, INC.Indego Therapy — Ekso Bionics, Inc.
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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