FDA 510(k) Application Details - K102278

Device Classification Name	Stimulator, Nerve, Transcutaneous, For Pain Relief   More FDA Info for this Device
510(K) Number	K102278
Device Name	Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant	GRADIENT TECHNOLOGIES, LLC 6070 POPLAR AVENUE SIXTH FLOOR MEMPHIS, TN 38119 US Other 510(k) Applications for this Company
Contact	JOHN TOWNSEND 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	08/11/2010
Decision Date	10/20/2011
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