SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYSTEM SHORTS, MODELS 390, E20

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 System Abs, Models 390, E10, X10; Slendertone System Shorts, Models 390, E20.

Pre-market Notification Details

Device IDK070142
510k NumberK070142
Device Name:SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYSTEM SHORTS, MODELS 390, E20
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 Received2007-01-16
Decision Date2007-03-23
Summary:summary

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