SLENDERTONE FLEX MAX, MODEL 517 US

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 Flex Max, Model 517 Us.

Pre-market Notification Details

Device IDK100556
510k NumberK100556
Device Name:SLENDERTONE FLEX MAX, MODEL 517 US
ClassificationStimulator, Muscle, Powered, For Muscle Conditioning
Applicant BIO-MEDICAL RESEARCH, LTD. BMR HOUSE PARKMORE BUSINESS PARK, WEST Galway,  IE
ContactAnne-marie Keenan
CorrespondentAnne-marie Keenan
BIO-MEDICAL RESEARCH, LTD. BMR HOUSE PARKMORE BUSINESS PARK, WEST Galway,  IE
Product CodeNGX  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-03-01
Decision Date2010-08-02
Summary:summary

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