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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 K142369
Device Name Urinary Incontinence System
Applicant
Guangzhou Finecure Medical Equipment Co.,Ltd
F19, # 1 Kesheng Rd., Baiyun Torch, Bldg., # 1633
Beitai Raod,Baiyun
Guangzhou,  CN 510040
Applicant Contact Chiping Ma
Correspondent
Shenzhen Yoyatech Consulting Co.,Ltd
4th Floor, Jinhui Bldg., Nanhai Blvd., Nanshan District
Shenzhen,  CN 518000
Correspondent Contact Field Fu
Regulation Number876.5320
Classification Product Code
KPI  
Date Received08/25/2014
Decision Date 06/17/2015
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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