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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 K132998
Device Name WANDY SELF-ADHESIVE ELECTRODES
Applicant
Wandy Rubber Industrial Co., Ltd.
# 48 Ln. 392, Fu Teh 1st Rd.
New Taipei City,  TW 221
Applicant Contact JACK YI
Correspondent
Wandy Rubber Industrial Co., Ltd.
# 48 Ln. 392, Fu Teh 1st Rd.
New Taipei City,  TW 221
Correspondent Contact JACK YI
Regulation Number882.1320
Classification Product Code
GXY  
Date Received09/24/2013
Decision Date 12/20/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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