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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 K915210
Device Name ELECTRO-NERVE STIMULATOR TENS MODEL MICRO PLUS-A
Applicant
BIOMEDICAL LIFE SYSTEMS, INC.
1120 SYCAMORE AVE., STE F
P.O. BOX 1360
VISTA,  CA  92083
Applicant Contact RICHARD SAXON
Correspondent
BIOMEDICAL LIFE SYSTEMS, INC.
1120 SYCAMORE AVE., STE F
P.O. BOX 1360
VISTA,  CA  92083
Correspondent Contact RICHARD SAXON
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received11/18/1991
Decision Date 05/04/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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