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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 K163288
Device Name Pelvifine Pelvic Muscle Trainer
Applicant
Shenzhen Konmed Technology Co., Ltd.
703b, Haide Bldg. A, Nanxin Rd., Nanshan
Shenzhen,  CN 518000
Applicant Contact Tony Tony
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
Suite 306, Kecheng Mansion, # 121 Science Rd., Guangzhou
Science Park
Guangzhou,  CN 510663
Correspondent Contact Cassie Lee
Regulation Number876.5320
Classification Product Code
KPI  
Date Received11/22/2016
Decision Date 01/18/2018
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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