Identity
- Trade Name
- ReWalk(TM) Personal FDA UDI
- Generic Name
- Programmable ambulation exoskeleton, home-use FDA UDI
- Device Name
- Powered exoskeleton - community use FDA UDI
- Model / Reference
- 50-20-0002 FDA UDI
- Description
- Powered exoskeleton - community use FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00861803000310 FDA UDI
- FDA Product Code
- PHL FDA UDI
- GMDN Term
- Programmable ambulation exoskeleton, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.3480 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Programmable ambulation exoskeleton, home-use
ReWalk(TM) Personal by Lifeward, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ReWalk 7 Personal Exoskeleton Therapist Handheld Device — LIFEWARD, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Lifeward, Inc.
Sources (1)
- FDA UDI 82375fdf-29d8-4430-ade6-a74999c4c62d 34 fields · synced May 31, 2026