FDA 510(k) Application Details - K143268

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K143268
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	SHENZHEN AS-TEC TECHNOLOGY CO., LTD 2C XINGBAOYI INDUSTRIAL BLD., HOUTING VILLAGE, BEITING RD., SHAJING SHENZHEN 518104 CN Other 510(k) Applications for this Company
Contact	CONNIE LI 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	11/13/2014
Decision Date	07/21/2015
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	N
Expedited Review