Revitive IX (OTC)
by Actegy, Ltd.
510(k) K143207
Revitive IX (OTC) is a Class II device made by Actegy, Ltd., cleared under FDA 510(k) K143207 on 23 Mar 2015, 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 | FDA 510(k)SESE | NumberK143207 | Date23 Mar 2015 | StatusActive |
Official records
- FDA 510(k) database K143207
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NGX
- FDA applicant
- Actegy , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 890.5850
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K143207
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Revitive Circulation Booster RIX | 1718 / RIX | 00858058005016 | — | On the market |
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