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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 K903128
Device Name STIMTRAC PC, CATALOG NO. 78-8510
Applicant
STIMTECH PRODUCTS
EAST MAIN ST.
P.O. BOX 10
SOUTHBRIDGE,  MA  01550
Applicant Contact WASON, PHD
Correspondent
STIMTECH PRODUCTS
EAST MAIN ST.
P.O. BOX 10
SOUTHBRIDGE,  MA  01550
Correspondent Contact WASON, PHD
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received07/16/1990
Decision Date 01/02/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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