FDA 510(k) Application Details - K201845

Device Classification Name	Stimulator, Muscle, Powered, For Muscle Conditioning   More FDA Info for this Device
510(K) Number	K201845
Device Name	Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant	Guangzhou Longest Science & Technology Co., LTD. 5 & 6f, Building B4, No. 11, Kaiyuan Avenue, Science City Guangzhou 510530 CN Other 510(k) Applications for this Company
Contact	Xiaobing Luo Other 510(k) Applications for this Contact
Regulation Number	890.5850   More FDA Info for this Regulation Number
Classification Product Code	NGX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/06/2020
Decision Date	10/08/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review