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 |