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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 K880545
Device Name STIMWEAR GARMENTS, SIGNAL I AND SIGNAL II
Applicant
Stimwear
12900 Lake Ave. Suite 1623
Lakewood,  OH  44107
Applicant Contact PHILIP MUCCIO, CPO
Correspondent
Stimwear
12900 Lake Ave. Suite 1623
Lakewood,  OH  44107
Correspondent Contact PHILIP MUCCIO, CPO
Regulation Number882.1320
Classification Product Code
GXY  
Date Received02/09/1988
Decision Date 05/31/1988
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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