FDA 510(k) Application Details - K172450

Device Classification Name	More FDA Info for this Device
510(K) Number	K172450
Device Name	TENS device-HeadaTerm, eEspress
Applicant	WAT Medical Technology (Ningbo) Co., Ltd Room703-711, No.2 North Taoyuan Road Ningbo 315600 CN Other 510(k) Applications for this Company
Contact	Rodney Zhang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PCC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/14/2017
Decision Date	09/13/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review