Replexa+ Device C1416
Replexa+ Device C1416 is a Class II device made by Promedtek, Inc., cleared under FDA 510(k) K162240 on 17 Nov 2016 and listed in FDA GUDID since 8 Jul 2019 (UDI-DI 00850886008009), 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 | Number00850886008009 | Date8 Jul 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK162240 | Date17 Nov 2016 | StatusActive |
Official records
- AccessGUDID record 00850886008009
- FDA 510(k) database K162240
Across registries
- FDA 510(k) K162240 decided 17 Nov 2016 Active
- FDA GUDID UDI-DI 00850886008009 listed 8 Jul 2019 Listed
Timeline
- Cleared FDA 510(k) K162240
- Listed FDA GUDID 00850886008009
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Replexa+ Device
- Generic name
- Short-wave diathermy treatment system, professional
- Model / reference
- C1416
- Primary DI / UDI-DI
- 00850886008009
- 510(k) Number
- FDA product code
- IMJ
- GMDN term
- Short-wave diathermy treatment system, professional
- Device class
- Class II
- Regulation number
- 890.5290
- GUDID distribution status
- In Commercial Distribution
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