R82 Multi Frame SIZE-2
R82 Multi Frame SIZE-2 (972110210) is a Class I device made by R82 a/S, cleared under FDA 510(k) K100084 on 12 Apr 2010 and listed in FDA GUDID since 12 Oct 2022 (UDI-DI 05707292591999), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05707292591999 | Date12 Oct 2022 | StatusListed |
| United States | FDA 510(k) | NumberK100084 | Date12 Apr 2010 | StatusActive |
Official records
- AccessGUDID record 05707292591999
- FDA 510(k) database K100084
Across registries
- FDA 510(k) K100084 decided 12 Apr 2010 Active
- FDA GUDID UDI-DI 05707292591999 listed 12 Oct 2022 Listed
Timeline
- Cleared FDA 510(k) K100084
- Listed FDA GUDID 05707292591999
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- R82
- Generic name
- Push-rim manual wheelchair, non-bariatric
- Model / Ref / Catalog
- Multi Frame SIZE-2, 972110210
- Primary DI / UDI-DI
- 05707292591999
- 510(k) Number
- FDA product code
- IOR
- GMDN term
- Push-rim manual wheelchair, non-bariatric
- Device class
- Class I
- Regulation number
- 890.3850
- GUDID distribution status
- In Commercial Distribution
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