FDA 510(k) Application Details - K021952

Device Classification Name	Stimulator, Nerve, Transcutaneous, For Pain Relief   More FDA Info for this Device
510(K) Number	K021952
Device Name	Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant	HIVOX BIOTEK, INC. NO. 58, FU-CHIUN ST. HSIN-CHU CITY TW Other 510(k) Applications for this Company
Contact	Ke-Min Jen 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	06/13/2002
Decision Date	05/02/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review