FDA 510(k) Application Details - K202110

Device Classification Name	Stimulator, Neuromuscular, External Functional   More FDA Info for this Device
510(K) Number	K202110
Device Name	Stimulator, Neuromuscular, External Functional
Applicant	Guangzhou Longest Science & Technology CO., Ltd. 5&6F, Building B4, No.11, Kaiyuan Avenue, Science City, Guangzhou Hi-tech In Guangzhou 510530 CN Other 510(k) Applications for this Company
Contact	Xiaobing Luo Other 510(k) Applications for this Contact
Regulation Number	882.5810   More FDA Info for this Regulation Number
Classification Product Code	GZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/30/2020
Decision Date	11/05/2021
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