BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294

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 Bmr Neurotech Back Tens And Lumbar Support Device. Type 294.

Pre-market Notification Details

Device IDK023916
510k NumberK023916
Device Name:BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294
ClassificationStimulator, Nerve, Transcutaneous, For Pain Relief
Applicant BIO-MEDICAL RESEARCH, LTD. PARKMORE BUSINESS PARK, West Galway,  IE
ContactMichelle Sawyer
CorrespondentMichelle Sawyer
BIO-MEDICAL RESEARCH, LTD. PARKMORE BUSINESS PARK, West Galway,  IE
Product CodeGZJ  
Subsequent Product CodeGXY
Subsequent Product CodeIQE
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-11-25
Decision Date2004-04-15
Summary:summary

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