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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K023916
Device Name BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294
Applicant
BIO-MEDICAL RESEARCH, LTD.
PARKMORE BUSINESS PARK,
WEST GALWAY,  IE
Applicant Contact MICHELLE SAWYER
Correspondent
BIO-MEDICAL RESEARCH, LTD.
PARKMORE BUSINESS PARK,
WEST GALWAY,  IE
Correspondent Contact MICHELLE SAWYER
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Codes
GXY   IQE  
Date Received11/25/2002
Decision Date 04/15/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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