The following data is part of a premarket notification filed by Actegy Ltd with the FDA for Revitive Ix.
| Device ID | K123354 |
| 510k Number | K123354 |
| Device Name: | REVITIVE IX |
| Classification | Stimulator, Muscle, Powered |
| Applicant | Actegy Ltd 555 13TH STREET, NW Washington, DC 20004 |
| Contact | John J Smith |
| Correspondent | John J Smith Actegy Ltd 555 13TH STREET, NW Washington, DC 20004 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-31 |
| Decision Date | 2013-06-28 |
| Summary: | summary |