FDA 510(k) Application Details - K210441

Device Classification Name	Stimulator, Electrical, Non-Implantable, For Incontinence   More FDA Info for this Device
510(K) Number	K210441
Device Name	Stimulator, Electrical, Non-Implantable, For Incontinence
Applicant	Shenzhen Med-link Electronics Tech Co, Ltd 4th And 5th Floor, Building Two, Hualian Industrial Zone, Xinshi Community Dalang Street Shenzhen 518109 CN Other 510(k) Applications for this Company
Contact	Yongfen Yang 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	02/12/2021
Decision Date	09/17/2021
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