Revitive IX (OTC)

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 Ix (otc).

Pre-market Notification Details

Device IDK143207
510k NumberK143207
Device Name:Revitive IX (OTC)
ClassificationStimulator, Muscle, Powered, For Muscle Conditioning
Applicant Actegy, Ltd 8 Queen Square, Ascot Business Park Lyndhurst Road Ascot,  GB Sl5 9fe
ContactAngela Glover
CorrespondentJohn J. Smith
Hogan Lovells US LLP Columbia Square 555 13th Street, NW Washington,  DC  20004
Product CodeNGX  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-11-07
Decision Date2015-03-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10858058005013 K143207 000

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