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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 K901704
Device Name RELIEF BAND (T.E.N.S. DEVICE)
Applicant
Maven Labs, Inc.
1401 21st St.
Suite 340
Sacramento,  CA  95814
Applicant Contact GAROLD G BREIT
Correspondent
Maven Labs, Inc.
1401 21st St.
Suite 340
Sacramento,  CA  95814
Correspondent Contact GAROLD G BREIT
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received04/12/1990
Decision Date 11/19/1991
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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