Identity
- Trade Name
- STRONGBACK FDA UDI
- Generic Name
- Push-rim manual wheelchair, bariatric FDA UDI
- Device Name
- - Self-proppelled wheelchair - Seat width: 22”/55 cm - Drum brakes - Quick release rear wheel: 24”/61 cm - Solid armrests FDA UDI
- Model / Reference
- 1036+AB/053 FDA UDI
- Description
- - Self-proppelled wheelchair - Seat width: 22”/55 cm - Drum brakes - Quick release rear wheel: 24”/61 cm - Solid armrests FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640176290923 FDA UDI
- FDA Product Code
- IOR FDA UDI
- GMDN Term
- Push-rim manual wheelchair, bariatric 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: Push-rim manual wheelchair, bariatric
Discover the STRONGBACK wheelchair, a self-propelled mobility device designed for individuals with bariatric needs. With its oversized seat and pair of larger wheels attached to specially designed rims, this non-powered wheeled personal mobility device enables users to propel themselves by rotating both wheels while seated.
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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 3fec11e1-44b7-4dfb-b090-0b7e7c103fb2 33 fields · synced Jul 12, 2026