FDA 510(k) Application Details - K080221

Device Classification Name	Stimulator, Nerve, Transcutaneous, For Pain Relief   More FDA Info for this Device
510(K) Number	K080221
Device Name	Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant	HELIO MEDICAL SUPPLIES, INC. 606 CHARCOT AVE. SAN JOSE, CA 95131 US Other 510(k) Applications for this Company
Contact	YUKUO HSO 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	01/29/2008
Decision Date	09/09/2008
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