Richmar 400-895
Richmar 400-895 is a Class II device made by South Dakota Partners, cleared under FDA 510(k) K223775 on 3 Jan 2023 and listed in FDA GUDID since 2 Aug 2023 (UDI-DI 00850030915542), 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 | Number00850030915542 | Date2 Aug 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK223775 | Date3 Jan 2023 | StatusActive |
Official records
- AccessGUDID record 00850030915542
- FDA 510(k) database K223775
Across registries
- FDA 510(k) K223775 decided 3 Jan 2023 Active
- FDA GUDID UDI-DI 00850030915542 listed 2 Aug 2023 Listed
Timeline
- Cleared FDA 510(k) K223775
- Listed FDA GUDID 00850030915542
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Richmar
- Generic name
- Transcutaneous electrical stimulation electrode, reusable
- Model / Ref / Catalog
- 400-895
- Primary DI / UDI-DI
- 00850030915542
- 510(k) Number
- FDA product code
- GXY
- GMDN term
- Transcutaneous electrical stimulation electrode, reusable
- Device class
- Class II
- Regulation number
- 882.1320
- GUDID distribution status
- In Commercial Distribution
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