The following data is part of a premarket notification filed by Actegy, Ltd. with the FDA for Revitive Medic; Revitive Mv; Revitive Lv.
| Device ID | K152480 |
| 510k Number | K152480 |
| Device Name: | Revitive Medic; Revitive MV; Revitive LV |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | Actegy, Ltd. Reflex, Cain Road Bracknell, GB Rg12 1hl |
| Contact | Angela Glover |
| Correspondent | Deanna Hughes DOHMEN LIFE SCIENCE SERVICES, LLC 11925 W I-70 FRONTAGE RD. NORTH, SUITE 900 Wheat Ridge, CO 80033 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-31 |
| Decision Date | 2016-03-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10858058005099 | K152480 | 000 |
| 10858058005082 | K152480 | 000 |
| 10858058005105 | K152480 | 000 |
| 10858058005259 | K152480 | 000 |