FDA 510(k) Application Details - K182108

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K182108
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	Guangzhou Longest Science & Technology Co., Ltd. 5&6f, Building B4, No.11, Kaiyuan Avenue Science City Hi-Tech Industrial Zone Guangzhou 510530 CN Other 510(k) Applications for this Company
Contact	Xiaobing Luo 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	08/03/2018
Decision Date	04/26/2019
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