The following data is part of a premarket notification filed by Actegy, Ltd. with the FDA for Revitive Medic Coach (model Number 5575aq).
| Device ID | K210825 |
| 510k Number | K210825 |
| Device Name: | Revitive Medic Coach (Model Number 5575AQ) |
| 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 | 2021-03-19 |
| Decision Date | 2021-12-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10858058005228 | K210825 | 000 |