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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Needle, Diagnostic Electromyograph
510(k) Number K152984
Device Name Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes
Applicant
Bio Protech, Inc.
Donghwa Medical Instrument Complex, 151-3,
Donghwagondan-Ro, Munmak-Eup
Wonju-Si,  KR 220-801
Applicant Contact DANIEL WOO
Correspondent
Bio Protech USA, Inc.
2601 Walnut Ave.
Tustin,  CA  92780
Correspondent Contact KEVIN HAN
Regulation Number890.1385
Classification Product Code
IKT  
Subsequent Product Code
GXZ  
Date Received10/09/2015
Decision Date 06/03/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
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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