FDA 510(k) Application Details - K111654

Device Classification Name	Stimulator, Nerve, Transcutaneous, For Pain Relief   More FDA Info for this Device
510(K) Number	K111654
Device Name	Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant	FUJI DYNAMICS LTD UNIT 1-3, 23/F LAWS COMMERICAL PLAZA 788 CHEUNG SHA WAN RD HONG KONG CH CN Other 510(k) Applications for this Company
Contact	CHING KONG (FELIX) LEE 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	06/13/2011
Decision Date	03/01/2012
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