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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 K932849
Device Name PMI TENS ELECTRODE
Applicant
Pepin Mfg., Inc.
800 Levanger Ln.
Stoughton,  WI  53589
Applicant Contact JEFF SOLBERG
Correspondent
Pepin Mfg., Inc.
800 Levanger Ln.
Stoughton,  WI  53589
Correspondent Contact JEFF SOLBERG
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received06/10/1993
Decision Date 01/27/1994
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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