FDA 510(k) Application Details - K130802

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K130802
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. XILIXIAOBAIMANG SHENZHEN, GUANGDONG 518108 CN Other 510(k) Applications for this Company
Contact	JIANPING KANG 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	03/22/2013
Decision Date	09/16/2013
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