FDA 510(k) Application Details - K033857

Device Classification Name	Stimulator, Nerve, Transcutaneous, For Pain Relief   More FDA Info for this Device
510(K) Number	K033857
Device Name	Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant	WELL-LIFE HEALTHCARE, INC. 6C01, NO.5, SEC.5, HSIN YI RD. TAIPEI 106 TW Other 510(k) Applications for this Company
Contact	JENNY HSIAH 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	12/11/2003
Decision Date	12/19/2003
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