SLENDERTONE FLEX, MODEL, 512

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, Model, 512.

Pre-market Notification Details

Device IDK010335
510k NumberK010335
Device Name:SLENDERTONE FLEX, MODEL, 512
ClassificationStimulator, Muscle, Powered, For Muscle Conditioning
Applicant BIO-MEDICAL RESEARCH, LTD. 700 13TH ST. NW SUITE 1200 Washington,  DC  20005
ContactRobert Dormer
CorrespondentRobert Dormer
BIO-MEDICAL RESEARCH, LTD. 700 13TH ST. NW SUITE 1200 Washington,  DC  20005
Product CodeNGX  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-02-02
Decision Date2001-09-27

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