SLENDERTONE ENERVIVE, MODEL 561

Stimulator, Muscle, Powered, For Muscle Conditioning

BIO-MEDICAL RESEARCH CORP.

The following data is part of a premarket notification filed by Bio-medical Research Corp. with the FDA for Slendertone Enervive, Model 561.

Pre-market Notification Details

Device IDK071666
510k NumberK071666
Device Name:SLENDERTONE ENERVIVE, MODEL 561
ClassificationStimulator, Muscle, Powered, For Muscle Conditioning
Applicant BIO-MEDICAL RESEARCH CORP. PARKMORE BUSINESS PARK WEST Galway,  IE
ContactAnne-marie Keenan
CorrespondentAnne-marie Keenan
BIO-MEDICAL RESEARCH CORP. PARKMORE BUSINESS PARK WEST Galway,  IE
Product CodeNGX  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-06-18
Decision Date2008-03-12
Summary:summary

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