sensiFirm CEL100US01SNS
sensiFirm CEL100US01SNS is a Class II device made by El Global Trade Ltd, cleared under FDA 510(k) K170637 on 14 Jul 2017 and listed in FDA GUDID since 16 Aug 2017 (UDI-DI 05060445341118), 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 | Number05060445341118 | Date16 Aug 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK170637 | Date14 Jul 2017 | StatusActive |
Official records
- AccessGUDID record 05060445341118
- FDA 510(k) database K170637
Across registries
- FDA 510(k) K170637 decided 14 Jul 2017 Active
- FDA GUDID UDI-DI 05060445341118 listed 16 Aug 2017 Listed
Timeline
- Cleared FDA 510(k) K170637
- Listed FDA GUDID 05060445341118
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- sensiFirm
- Generic name
- Radio-frequency skin surface treatment system
- Model / reference
- CEL100US01SNS
- Primary DI / UDI-DI
- 05060445341118
- 510(k) Number
- FDA product code
- GEI, PBX
- GMDN term
- Radio-frequency skin surface treatment system
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Radio-frequency skin surface treatment system.