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 |