FDA 510(k) Application Details - K003487

Device Classification Name	Stimulator, Nerve, Transcutaneous, For Pain Relief   More FDA Info for this Device
510(K) Number	K003487
Device Name	Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant	EVERYWAY MEDICAL INSTRUMENTS CO., LTD. 2FL NO. 1-2 TSAO TI WEI, SHEN KENG HSIANG TAIPEI HSIEN, TW Other 510(k) Applications for this Company
Contact	DORA HSU YANG 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	11/13/2000
Decision Date	01/24/2001
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