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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 K020712
Device Name ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-4
Applicant
Biomedical Life Systems, Inc.
2448 Cades Way
Vista,  CA  92083
Applicant Contact RICHARD SAXON
Correspondent
Biomedical Life Systems, Inc.
2448 Cades Way
Vista,  CA  92083
Correspondent Contact RICHARD SAXON
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received03/05/2002
Decision Date 09/24/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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