The following data is part of a premarket notification filed by Actegy, Ltd with the FDA for Revitive Ix (otc).
| Device ID | K143207 |
| 510k Number | K143207 |
| Device Name: | Revitive IX (OTC) |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | Actegy, Ltd 8 Queen Square, Ascot Business Park Lyndhurst Road Ascot, GB Sl5 9fe |
| Contact | Angela Glover |
| Correspondent | John J. Smith Hogan Lovells US LLP Columbia Square 555 13th Street, NW Washington, DC 20004 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-07 |
| Decision Date | 2015-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10858058005013 | K143207 | 000 |