Slendertone Connect Abs

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 Connect Abs.

Pre-market Notification Details

Device IDK151903
510k NumberK151903
Device Name:Slendertone Connect Abs
ClassificationStimulator, Muscle, Powered, For Muscle Conditioning
Applicant BIO-MEDICAL RESEARCH LTD. PARKMORE BUSINESS PARK WEST Galway,  IE
ContactAnne-marie Keenan
CorrespondentAnne-marie Keenan
BIO-MEDICAL RESEARCH LTD. PARKMORE BUSINESS PARK WEST Galway,  IE
Product CodeNGX  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-10
Decision Date2015-11-06
Summary:summary

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