FDA 510(k) Application Details - K161091

Device Classification Name	Stimulator, Nerve, Transcutaneous, For Pain Relief   More FDA Info for this Device
510(K) Number	K161091
Device Name	Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant	XAVANT TECHNOLOGY (PTY) LTD Unit 102 The Tannery Industrial Park 309 Derdepoort Road Silverton 0184 ZA Other 510(k) Applications for this Company
Contact	Roche Janse van Rensberg 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	04/18/2016
Decision Date	01/18/2017
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