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 |