Setmark Incorporated WC-104B
by Setmark Inc.
Setmark Incorporated WC-104B is a wheelchair (FDA Class I; FDA product code IOR, Wheelchair, Mechanical) made by Setmark Inc., cleared under FDA 510(k) K973418 on 9 Oct 1997 and listed in FDA GUDID since 31 Jan 2018 (UDI-DI 00854204008108), 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 | Number00854204008108 | Date31 Jan 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK973418 | Date9 Oct 1997 | StatusActive |
Official records
- AccessGUDID record 00854204008108
- FDA 510(k) database K973418
Across registries
- FDA 510(k) K973418 decided 9 Oct 1997 Active
- FDA GUDID UDI-DI 00854204008108 listed 31 Jan 2018 Listed
Timeline
- Cleared FDA 510(k) K973418
- Listed FDA GUDID 00854204008108
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Setmark Incorporated
- Generic name
- Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible
- Model / reference
- WC-104B
- Primary DI / UDI-DI
- 00854204008108
- 510(k) Number
- FDA product code
- IOR
- GMDN term
- Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible
- Device class
- Class I
- Regulation number
- 890.3850
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
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