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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Non-Implantable, For Incontinence
510(k) Number K161349
Device Name Everyway Incontinence Stimulation System
Applicant
Everyway Medical Instrument Co., Ltd.
3fl., # 5, Ln. 155, Section 3, Peishen Rd.,
Shenkeng District, New Taipei City,  CN 22203
Applicant Contact ROBERT TU
Correspondent
Everyway Medical Instrument Co., Ltd.
3fl., # 5, Ln. 155, Section 3, Peishen Rd.,
Shenkeng District, New Taipei City,  CN 22203
Correspondent Contact ROBERT TU
Regulation Number876.5320
Classification Product Code
KPI  
Date Received05/16/2016
Decision Date 07/07/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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