SLENDERTONE SYSTEM ULTRA MODEL E70/X70

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 System Ultra Model E70/x70.

Pre-market Notification Details

Device IDK100320
510k NumberK100320
Device Name:SLENDERTONE SYSTEM ULTRA MODEL E70/X70
ClassificationStimulator, Muscle, Powered, For Muscle Conditioning
Applicant BIO-MEDICAL RESEARCH, LTD. PARKMORE BUSINESS PARK, WEST Galway,  IE
ContactDeirdre Barrow
CorrespondentDeirdre Barrow
BIO-MEDICAL RESEARCH, LTD. PARKMORE BUSINESS PARK, WEST Galway,  IE
Product CodeNGX  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-02-04
Decision Date2010-05-05
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.