Identity
- Trade Name
- STRONGBACK FDA UDI
- Generic Name
- Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible FDA UDI
- Device Name
- - Self-proppelled wheelchair - Seat width: 20”/50 cm - Quick release rear wheel: 24”/61 cm FDA UDI
- Model / Reference
- 1010/003 FDA UDI
- Description
- - Self-proppelled wheelchair - Seat width: 20”/50 cm - Quick release rear wheel: 24”/61 cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640176290039 FDA UDI
- FDA Product Code
- IOR FDA UDI
- GMDN Term
- Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3850 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
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible
Strongback by Strongback Mobility Usa, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Invacare® MyOn™ Ultralightweight Folding Wheelchair — Invacare Corp. · 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 |
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Manufacturer
- Manufacturer
- Strongback Mobility Usa, Llc
Sources (1)
- FDA UDI 5f2fbc59-980f-49bb-a63d-db96e9da2fa4 34 fields · synced May 30, 2026