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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(k) Number K103031
Device Name BMR FACE
Applicant
BIO-MEDICAL RESEARCH, LTD.
BMR HOUSE
PARKMORE BUSINESS PARK, WEST
GALWAY,  IE EI
Applicant Contact ANNE-MARIE KEENAN
Correspondent
BIO-MEDICAL RESEARCH, LTD.
BMR HOUSE
PARKMORE BUSINESS PARK, WEST
GALWAY,  IE EI
Correspondent Contact ANNE-MARIE KEENAN
Regulation Number882.5890
Classification Product Code
NFO  
Date Received10/12/2010
Decision Date 11/10/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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