FDA 510(k) Application Details - K123099

Device Classification Name	Stimulator, Nerve, Transcutaneous, For Pain Relief   More FDA Info for this Device
510(K) Number	K123099
Device Name	Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant	AVAZZIA, INC. 13140 Coit Rd Ste 515 DALLAS, TX 75240 US Other 510(k) Applications for this Company
Contact	TAMMY LAHUTSKY 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	10/02/2012
Decision Date	05/23/2014
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