Bounder Bounder 300
by 21ST Century Scientific, Inc.
Bounder 300 is an electric-motor-driven wheelchair (FDA Class II; FDA product code ITI, Wheelchair, Powered) made by 21ST Century Scientific, Inc., cleared under FDA 510(k) K193599 on 3 Sep 2020 and listed in FDA GUDID since 24 Sep 2020 (UDI-DI 00861980000431), 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 | Number00861980000431 | Date24 Sep 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK193599 | Date3 Sep 2020 | StatusActive |
Official records
- AccessGUDID record 00861980000431
- FDA 510(k) database K193599
Across registries
- FDA 510(k) K193599 decided 3 Sep 2020 Active
- FDA GUDID UDI-DI 00861980000431 listed 24 Sep 2020 Listed
Timeline
- Cleared FDA 510(k) K193599
- Listed FDA GUDID 00861980000431
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Bounder
- Generic name
- Electric-motor-driven wheelchair, occupant-controlled
- Model / reference
- BOUNDER 300
- Primary DI / UDI-DI
- 00861980000431
- 510(k) Number
- FDA product code
- ITI
- GMDN term
- Electric-motor-driven wheelchair, occupant-controlled
- Device class
- Class II
- Regulation number
- 890.3860
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Electric-motor-driven wheelchair, occupant-controlled.