Revitive Medic Coach (Model Number 5575AQ)

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 Coach (model Number 5575aq).

Pre-market Notification Details

Device IDK210825
510k NumberK210825
Device Name:Revitive Medic Coach (Model Number 5575AQ)
ClassificationStimulator, Muscle, Powered, For Muscle Conditioning
Applicant Actegy, Ltd. Reflex, Cain Road Bracknell,  GB Rg12 1hl
ContactLawrence Brookfield
CorrespondentCarmelina Allis
The Allis Law Firm, PLLC 2532 North Fourth Street, #620 Flagstaff,  AZ  86004
Product CodeNGX  
Subsequent Product CodeGZJ
Subsequent Product CodeIPF
Subsequent Product CodeNUH
Subsequent Product CodeNYN
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-19
Decision Date2021-12-17

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