SLENDERTONE Evolve Abs, Type 735

Stimulator, Muscle, Powered, For Muscle Conditioning

Bio-Medical Research Ltd

The following data is part of a premarket notification filed by Bio-medical Research Ltd with the FDA for Slendertone Evolve Abs, Type 735.

Pre-market Notification Details

Device IDK203513
510k NumberK203513
Device Name:SLENDERTONE Evolve Abs, Type 735
ClassificationStimulator, Muscle, Powered, For Muscle Conditioning
Applicant Bio-Medical Research Ltd Parkmore Business Park West Galway,  IE H91 Nht7
ContactEoin Keating
CorrespondentEoin Keating
Bio-Medical Research Ltd Parkmore Business Park West Galway,  IE H91 Nht7
Product CodeNGX  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-30
Decision Date2021-02-10

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