FDA 510(k) Application Details - K161537

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K161537
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD 2ND &3RD FLOOR, BLD.6 DAPIAN INDUSTRIAL ZONE, TANGXIA RD., TIANHE DISTRICT GUANGZHOU 510665 CN Other 510(k) Applications for this Company
Contact	WENDY POON Other 510(k) Applications for this Contact
Regulation Number	882.5890   More FDA Info for this Regulation Number
Classification Product Code	NUH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/03/2016
Decision Date	10/13/2016
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