FDA 510(k) Application Details - K220161

Device Classification Name	Stimulator, Electrical, Non-Implantable, For Incontinence   More FDA Info for this Device
510(K) Number	K220161
Device Name	Stimulator, Electrical, Non-Implantable, For Incontinence
Applicant	Shenzhen Konmed Technology Co.,Ltd. 601, Building B4, Shenchengtou Creative Factory Life Science Park, Julongshan A Road Shenzhen 518118 CN Other 510(k) Applications for this Company
Contact	ShuiShan Yin 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	01/20/2022
Decision Date	07/20/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review