Identity
- Trade Name
- Gait Belt FDA UDI
- Generic Name
- Gait rehabilitation system harness FDA UDI
- Device Name
- Gait Belt, Wipeable, Vinyl, Plastic Buckle, Red and Black FDA UDI
- Model / Reference
- 4345 FDA UDI
- Description
- Gait Belt, Wipeable, Vinyl, Plastic Buckle, Red and Black FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00616784434513 FDA UDI
- FDA Product Code
- IKX FDA UDI
- GMDN Term
- Gait rehabilitation system harness FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5050 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Gait rehabilitation system harness
Gait Belt by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gait rehabilitation system harness.
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- MediChoice — OWENS & MINOR DISTRIBUTION, INC. · Class I
- Aretech Premium Harness — ARETECH, LLC · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- 30" WOOD TRANSFER BOARD — BIRD & CRONIN, LLC · Class I
- E.M Adams co, inc. — E.M. Adams · Class I
- 54" WALKING BELT BLUE — BIRD & CRONIN, LLC · Class I
- Aretech Premium Harness — ARETECH, LLC · 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dynarex Corp.
Sources (1)
- FDA UDI cb51d2b0-299d-46fe-b418-84f345f30ee5 33 fields · synced May 30, 2026