Revitive Medic Plus 3156AD
by Actegy, Ltd.
Revitive Medic Plus 3156AD (3158) is a medical device (FDA Class II) made by Actegy, Ltd., cleared under FDA 510(k) K190924 on 5 Jul 2019 and listed in FDA GUDID since 9 Oct 2019 (UDI-DI 00858058005146), 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 | Number00858058005146 | Date9 Oct 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK190924 | Date5 Jul 2019 | StatusActive |
Official records
- AccessGUDID record 00858058005146
- FDA 510(k) database K190924
Across registries
- FDA 510(k) K190924 decided 5 Jul 2019 Active
- FDA GUDID UDI-DI 00858058005146 listed 9 Oct 2019 Listed
Timeline
- Cleared FDA 510(k) K190924
- Listed FDA GUDID 00858058005146
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Revitive Medic Plus
- Generic name
- Analgesic transcutaneous electrical nerve stimulation system
- Model / Ref / Catalog
- 3156AD, 3158
- Primary DI / UDI-DI
- 00858058005146
- 510(k) Number
- FDA product code
- NYN, IPF, GZJ, NUH, NGX
- GMDN term
- Analgesic transcutaneous electrical nerve stimulation system
- Device class
- Class II
- Regulation number
- 882.5890, 890.5850
- GUDID distribution status
- In Commercial Distribution
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