FDA 510(k) Application Details - K161453

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K161453
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	WELL-LIFE HEALTHCARE LIMITED 1F, NO.16, LANE 454 JUNGJENG ROAD YUNGHE CITY, TAIPEI COUNTY 234 TW Other 510(k) Applications for this Company
Contact	CHIN-CHIH HSIEH Other 510(k) Applications for this Contact
Regulation Number	882.5890   More FDA Info for this Regulation Number
Classification Product Code	NUH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/26/2016
Decision Date	12/05/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review