FDA 510(k) Application Details - K160246

Device Classification Name	Stimulator, Nerve, Transcutaneous, For Pain Relief   More FDA Info for this Device
510(K) Number	K160246
Device Name	Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant	XANACARE TECHNOLOGIES, LLC 9185 EAST KENYON AVENUE # 270 DENVER, CO 80237-1857 US Other 510(k) Applications for this Company
Contact	THOMAS C SIIROLA Other 510(k) Applications for this Contact
Regulation Number	882.5890   More FDA Info for this Regulation Number
Classification Product Code	GZJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/01/2016
Decision Date	10/06/2016
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