FDA 510(k) Application Details - K112288

Device Classification Name	Stimulator, Nerve, Transcutaneous, For Pain Relief   More FDA Info for this Device
510(K) Number	K112288
Device Name	Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant	WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. ROOM 1706, NO.128 SONGLE RD SONGJIANG AREA SHANGHAI 201600 CN Other 510(k) Applications for this Company
Contact	DORIS DONG 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	08/09/2011
Decision Date	05/02/2012
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