Ulaif R-C1
by Shenzhen roundwhale technology co. LTD.
Ulaif R-C1 is a Class II device made by Shenzhen roundwhale technology co. LTD., cleared under FDA 510(k) K180956 on 7 Jun 2018 and listed in FDA GUDID since 16 Jul 2018 (UDI-DI 00840001700048), active as of 23 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 | Number00840001700048 | Date16 Jul 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK180956 | Date7 Jun 2018 | StatusActive |
Official records
- AccessGUDID record 00840001700048
- FDA 510(k) database K180956
Across registries
- FDA 510(k) K180956 decided 7 Jun 2018 Active
- FDA GUDID UDI-DI 00840001700048 listed 16 Jul 2018 Listed
Timeline
- Cleared FDA 510(k) K180956
- Listed FDA GUDID 00840001700048
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Ulaif
- Generic name
- Transcutaneous electrical stimulation probe
- Model / reference
- R-C1
- Primary DI / UDI-DI
- 00840001700048
- 510(k) Number
- FDA product code
- NUH
- GMDN term
- Transcutaneous electrical stimulation probe
- Device class
- Class II
- Regulation number
- 882.5890
- GUDID distribution status
- In Commercial Distribution
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