Identity
- Trade Name
- Healing Innovations FDA UDI
- Generic Name
- Gait rehabilitation frame, electric FDA UDI
- Device Name
- robotic neurorehabilitation device for gait training and additional therapy purposes FDA UDI
- Model / Reference
- RWC1000 FDA UDI
- Description
- robotic neurorehabilitation device for gait training and additional therapy purposes FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860003483206 FDA UDI
- FDA Product Code
- IKK FDA UDI
- GMDN Term
- Gait rehabilitation frame, electric FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.1925 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Gait rehabilitation frame, electric
Healing Innovations by Healing Innovations — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gait rehabilitation frame, electric.
- Vector Gait and Safety System — Bioness Medical, Inc. · Class I
- SafeGait 360 Balance and Mobility Trainer — DIH TECHNOLOGY INC. · Class I
- ZeroG-Lite Treadmill System — ARETECH, LLC · Class I
- Luminaire BWS Treadmill System — ARETECH, LLC · Class I
- Ovation 400 — ARETECH, LLC · Class I
- Ovation 700 — ARETECH, LLC · Class I
- SafeGait Active 360 Dynamic Mobility Trainer — DIH TECHNOLOGY INC. · Class I
- Vector Elite — BIONESS INC. · Class I
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
- Healing Innovations
Sources (1)
- FDA UDI d48b444f-e22c-4f60-bc42-16e00006c07c 33 fields · synced May 31, 2026