FDA 510(k) Application Details - K183674

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K183674
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	Shenzhen Leading Perfection Technology Co., Ltd 4th Floor, J Building, San Yi Dui Industrial Park, Zhoushi Road, Jiuwei Shenzhen 518101 CN Other 510(k) Applications for this Company
Contact	Simon Hou 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	12/27/2018
Decision Date	10/11/2019
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