Quickie S-646
Quickie S-646 (EIS62) is an electric-motor-driven wheelchair (FDA Class II; FDA product code ITI, Wheelchair, Powered) made by Sunrise Medical (US) LLC, cleared under FDA 510(k) K010917 on 15 May 2001 and listed in FDA GUDID since 3 May 2021 (UDI-DI 00016958044256), active as of 16 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 | Number00016958044256 | Date3 May 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK010917 | Date15 May 2001 | StatusActive |
Official records
- AccessGUDID record 00016958044256
- FDA 510(k) database K010917
Across registries
- FDA 510(k) K010917 decided 15 May 2001 Active
- FDA GUDID UDI-DI 00016958044256 listed 3 May 2021 Listed
Timeline
- Cleared FDA 510(k) K010917
- Listed FDA GUDID 00016958044256
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Electric-motor-driven wheelchair, occupant-controlled
- Model / Ref / Catalog
- S-646, EIS62
- Primary DI / UDI-DI
- 00016958044256
- 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.