FDA 510(k) Application Details - K053284

Device Classification Name	Stimulator, Nerve, Transcutaneous, For Pain Relief   More FDA Info for this Device
510(K) Number	K053284
Device Name	Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant	DURTECH SYSTEM CORP. 3F, NO. 27, LANE 381 FU-THE 1ST ROAD HIS-CHIH TAIPEI 221 TW Other 510(k) Applications for this Company
Contact	ADA LIN 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	11/25/2005
Decision Date	03/10/2006
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	Y
Expedited Review