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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 K862450
Device Name MEDA 2500 T.E.N.S.
Applicant
Watlow/Winona, Inc.
Medical Electronic Dealers Inc
350 S. Highland
Placentia,  CA  92670
Applicant Contact DENNIS MCGIMSEY
Correspondent
Watlow/Winona, Inc.
Medical Electronic Dealers Inc
350 S. Highland
Placentia,  CA  92670
Correspondent Contact DENNIS MCGIMSEY
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received06/27/1986
Decision Date 11/25/1986
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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