FDA 510(k) Application Details - K090922

Device Classification Name	Stimulator, Nerve, Transcutaneous, For Pain Relief   More FDA Info for this Device
510(K) Number	K090922
Device Name	Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant	EMPI CLEAR LAKE INDUSTRIAL PARK CLEAR LAKE, SD 57226 US Other 510(k) Applications for this Company
Contact	SANDRA WALROD 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	04/01/2009
Decision Date	06/05/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review