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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
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