FDA 510(k) Application Details - K201014

Device Classification Name	Stimulator, Electrical, Non-Implantable, For Incontinence   More FDA Info for this Device
510(K) Number	K201014
Device Name	Stimulator, Electrical, Non-Implantable, For Incontinence
Applicant	Thought Technology LTD. 5250 Ferrier, Suite 812 Montreal H4P 1L3 CA Other 510(k) Applications for this Company
Contact	Zena Butris 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	04/17/2020
Decision Date	01/13/2021
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