FDA 510(k) Application Details - K163470

Device Classification Name	Stimulator, Transcutaneous Electrical, Aesthetic Purposes   More FDA Info for this Device
510(K) Number	K163470
Device Name	Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant	ShenZhen Siken 3D Technology Development Co., Ltd. Siken Industrial Park, East Avenue No., 33 Songgang Street, Baoan District Shenzhen CN Other 510(k) Applications for this Company
Contact	Kimi Xue Other 510(k) Applications for this Contact
Regulation Number	882.5890   More FDA Info for this Regulation Number
Classification Product Code	NFO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/12/2016
Decision Date	06/02/2017
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