Revitive Medic; Revitive MV; Revitive LV

Stimulator, Muscle, Powered, For Muscle Conditioning

Actegy, Ltd.

The following data is part of a premarket notification filed by Actegy, Ltd. with the FDA for Revitive Medic; Revitive Mv; Revitive Lv.

Pre-market Notification Details

Device IDK152480
510k NumberK152480
Device Name:Revitive Medic; Revitive MV; Revitive LV
ClassificationStimulator, Muscle, Powered, For Muscle Conditioning
Applicant Actegy, Ltd. Reflex, Cain Road Bracknell,  GB Rg12 1hl
ContactAngela Glover
CorrespondentDeanna Hughes
DOHMEN LIFE SCIENCE SERVICES, LLC 11925 W I-70 FRONTAGE RD. NORTH, SUITE 900 Wheat Ridge,  CO  80033
Product CodeNGX  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-08-31
Decision Date2016-03-31

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10858058005099 K152480 000
10858058005082 K152480 000
10858058005105 K152480 000
10858058005259 K152480 000

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