FDA 510(k) Application Details - K213116

Device Classification Name	Stimulator, Electrical, Non-Implantable, For Incontinence   More FDA Info for this Device
510(K) Number	K213116
Device Name	Stimulator, Electrical, Non-Implantable, For Incontinence
Applicant	Everyway Medical Instruments Co., Ltd. 3FL., No. 5, Lane 155, Section 3, Beishen Rd., Shenkeng District, New Taipei City 22203 CN Other 510(k) Applications for this Company
Contact	Paul Hung 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	09/27/2021
Decision Date	12/03/2021
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