FDA 510(k) Application Details - K230782

Device Classification Name	More FDA Info for this Device
510(K) Number	K230782
Device Name	TENS device-HeadaTerm 2 (Model: YF-HT2)
Applicant	WAT Medical Technology Inc. Room703-711, No.2 North Taoyuan Road Ningbo 315600 CN Other 510(k) Applications for this Company
Contact	Joe Xu 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	03/22/2023
Decision Date	02/26/2024
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