The following data is part of a premarket notification filed by Actegy, Ltd. with the FDA for Revitive Medic Plus, Revitive Advanced 2.
Device ID | K192887 |
510k Number | K192887 |
Device Name: | Revitive Medic Plus, Revitive Advanced 2 |
Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
Applicant | Actegy, Ltd. Reflex, Cain Road Bracknell, GB Rg12 1hl |
Contact | Lawrence Brookfield |
Correspondent | Carmelina Allis The Allis Law Firm, PLLC 2532 North Fourth Street, #620 Flagstaff, AZ 86004 |
Product Code | NGX |
Subsequent Product Code | GZJ |
Subsequent Product Code | IPF |
Subsequent Product Code | NUH |
Subsequent Product Code | NYN |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-10-10 |
Decision Date | 2020-05-04 |