FDA 510(k) Application Details - K121305

Device Classification Name	Stimulator, Nerve, Transcutaneous, For Pain Relief   More FDA Info for this Device
510(K) Number	K121305
Device Name	Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant	ARMSTRONG INDUSTRIES, INC. DHA MEDIQUIP INT. DHA S 7290 VIRGINIA PARKWAY SUITE 3000 MCKINNEY, TX 75071 US Other 510(k) Applications for this Company
Contact	RALPH H ARMSTRONG 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	05/01/2012
Decision Date	09/25/2012
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