FDA 510(k) Application Details - K171430

Device Classification Name	Stimulator, Electrical, Non-Implantable, For Incontinence   More FDA Info for this Device
510(K) Number	K171430
Device Name	Stimulator, Electrical, Non-Implantable, For Incontinence
Applicant	Shenzhen Dongdixin Technology Co., Ltd No. 3 Building, XiLiBaimang Xusheng Industrial Estate Nanshan Shenzhen 518108 CN Other 510(k) Applications for this Company
Contact	Truman Shen Other 510(k) Applications for this Contact
Regulation Number	876.5320   More FDA Info for this Regulation Number
Classification Product Code	KPI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/15/2017
Decision Date	03/15/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review