SYSTEM-ARMS, MODEL 390,E60

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 System-arms, Model 390,e60.

Pre-market Notification Details

Device IDK072553
510k NumberK072553
Device Name:SYSTEM-ARMS, MODEL 390,E60
ClassificationStimulator, Muscle, Powered, For Muscle Conditioning
Applicant BIO-MEDICAL RESEARCH, LTD. PARKMORE BUSINESS PARK WEST Galway,  IE
ContactAnne-marie Keenan
CorrespondentAnne-marie Keenan
BIO-MEDICAL RESEARCH, LTD. PARKMORE BUSINESS PARK WEST Galway,  IE
Product CodeNGX  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-09-10
Decision Date2007-12-14
Summary:summary

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