Powered Exoskeleton
Physical Medicine · 21 CFR 890.3480
A powered exoskeleton is a prescription device that is composed of an external, powered, motorized orthosis that is placed over a person's paralyzed or weakened lower extremity limb(s) for medical purposes.
Recent MDR events
55 adverse event reports on file
- ReWalk Personal P6.0Jul 30, 2026InjuryLifeward Ltd.3007615665-2026-00001
- ATALANTE XDec 19, 2025InjuryWandercraft Sas3015000676-2025-00002
- KEEOGO-CLINICIAN KITOct 7, 2025InjuryB-temia3012602431-2025-00087
- KEEOGO - CLINICIAN KITSep 18, 2025InjuryB-temia Inc.3011819880-2025-00122
- KEEOGO - CLINICIAN KITSep 18, 2025InjuryB-temia Inc3011819880-2025-12200
- REWALK 7Aug 19, 2025InjuryLifeward Ltd.3007615665-2025-00001
- ATALANTE XApr 7, 2025InjuryWandercraft3015000676-2025-00001
- REWALK PERSONAL P6.0Dec 23, 2024InjuryLifeward Ltd.3007615665-2024-00004
- REWALK PERSONAL P6.0Nov 14, 2024InjuryLifeward Ltd.3007615665-2024-00003
- ATALANTE XOct 22, 2024InjuryWandercraft3015000676-2024-70002
Event type breakdown
Recalls
3 recall events for this product code
- WANDERCRAFT SASOpen, ClassifiedMay 8, 2025
Atalante X, Powered Exoskeleton.
Potential for exoskeleton to lose lateral balance and cause patient to fall.
Z-1739-2025 · View FDA record ↗ - Argo Medical Technologies LtdTerminatedUnknown
ReWalk Personal 6.0. Catalog number: 50-20-0004.
Firm received complaints for ReWalk Personal 6.0 of an injury to tibia and fibula.
Z-0944-2018 · View FDA record ↗ - Argo Medical Technologies LtdTerminatedUnknown
ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the lower limbs and part of the upper body and is intended to enable individu
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 battery packs) caught fire while being charged.
Z-1553-2021 · View FDA record ↗
Registered firms
26 firms currently registered for this product code
510(k) clearances
25 clearances for this product code
- Wandercraft SASAug 3, 2026
K260381 · Eve
- Wandercraft SASOct 24, 2025
K250904 · Atalante X
- Rewalk Robotics Ltd. Dba LifewardMar 12, 2025
K241822 · ReWalk® 7 Personal Exoskeleton (50-20-0005)
- Cyberdyne, Inc.May 7, 2024
K233695 · Medical HAL Lower Limb Type (HAL-ML)
- Wandercraft SASDec 13, 2023
K232077 · Atalante X
- Re Walk Robotics , Ltd.Mar 2, 2023
K221696 · ReWalk P6.0
- Wandercraft SASDec 29, 2022
K221859 · Atalante
- Ekso Bionics, Inc.Jun 9, 2022
K220988 · EksoNR