R82 Multi Frame SIZE-2
R82 Multi Frame SIZE-2 (972141210) 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 05707292566232), 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 | Number05707292566232 | Date12 Oct 2022 | StatusListed |
| United States | FDA 510(k) | NumberK100084 | Date12 Apr 2010 | StatusActive |
Official records
- AccessGUDID record 05707292566232
- FDA 510(k) database K100084
Across registries
- FDA 510(k) K100084 decided 12 Apr 2010 Active
- FDA GUDID UDI-DI 05707292566232 listed 12 Oct 2022 Listed
Timeline
- Cleared FDA 510(k) K100084
- Listed FDA GUDID 05707292566232
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- Withdrawn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, 972141210
- Primary DI / UDI-DI
- 05707292566232
- 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
Similar devices
Other devices filed under FDA product code IOR (Wheelchair, mechanical).
- J.A.G. LIGHTWEIGHT MANUAL WHEELCHAIR by Roll-Ability (Pty), Ltd.
- VOYAGER/VIPER WHEELCHAIR by Otto Bock Orthopedic Industry, Inc.
- SWEDE CHAMP (WHEELCHAIR) by Etac Us, Inc.
- QUICKIE CARBON WHEELCHAIR by Sunrise Medical Quickie Designs, Inc.
- THE REIFF QUANTUM WHEELCHAIR, OR QUANTUM WHEELCHAIRS by Reif Wheelchairs and Accessories, Inc.
- MEDLINE EXCEL RECLINCER WHEELCHAIR by MEDLINE INDUSTRIES, INC.
- SYRYKER SORANO WHEELCHAIR by Stryker Canada
- MANUAL WHEELCHAIR by Major Mobility Products, Inc.
- IMPALA by Pin Dot Products, Inc.
- TILITE EVO by Tisport