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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 K230767
Device Name Pelvic Floor Muscle Stimulator
Applicant
Nanjing Vishee Medical Technology Co., Ltd.
Bldg. 9, #19, Ningshuang Rd., Yuhuatai District
Nanjing,  CN 210012
Applicant Contact Qiu Kai
Correspondent
Nanjing Vishee Medical Technology Co., Ltd.
Bldg. 9, #19, Ningshuang Rd., Yuhuatai District
Nanjing,  CN 210012
Correspondent Contact Lisa Tan
Regulation Number876.5320
Classification Product Code
KPI  
Date Received03/20/2023
Decision Date 09/21/2023
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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