LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK

Stimulator, Nerve, Transcutaneous, For Pain Relief

BIO-MEDICAL RESEARCH, LTD.

The following data is part of a premarket notification filed by Bio-medical Research, Ltd. with the FDA for Lumbofix Conductive Garment, Model 420 Back.

Pre-market Notification Details

Device IDK091317
510k NumberK091317
Device Name:LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK
ClassificationStimulator, Nerve, Transcutaneous, For Pain Relief
Applicant BIO-MEDICAL RESEARCH, LTD. BMR HOUSE PARKMORE BUSINESS PARK, WEST Galway,  IE
ContactAnne-marie Keenan
CorrespondentAnne-marie Keenan
BIO-MEDICAL RESEARCH, LTD. BMR HOUSE PARKMORE BUSINESS PARK, WEST Galway,  IE
Product CodeGZJ  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-05-04
Decision Date2009-06-25
Summary:summary

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