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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K881444
Device Name T.E.N.S. ELECTRODE NON-STERILE
Applicant
Tens Accessories, Inc.
7406 Central Ave., NE
Minneapolis,  MN  55432
Applicant Contact WARREN HOCH
Correspondent
Tens Accessories, Inc.
7406 Central Ave., NE
Minneapolis,  MN  55432
Correspondent Contact WARREN HOCH
Regulation Number882.1320
Classification Product Code
GXY  
Date Received04/06/1988
Decision Date 06/10/1988
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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