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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 K173186
Device Name S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D
Applicant
Everyway Medical Instruments Co.,Ltd
3fl., # 5, Ln. 155, Sec. 3 Beishen Rd.
Shenkeng Dist.
New Taipei City,  TW 22203
Applicant Contact Paul Hung
Correspondent
Everyway Medical Instruments Co.,Ltd
3fl., # 5, Ln. 155, Sec. 3 Beishen Rd.
Shenkeng Dist.
New Taipei City,  TW 22203
Correspondent Contact Paul Hung
Regulation Number882.1320
Classification Product Code
GXY  
Date Received10/02/2017
Decision Date 02/28/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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