FDA 510(k) Application Details - K220005

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K220005
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	Shenzhen Yuehua Xinsen Technology Co., Ltd. No. 27-201, Zhongwu 3rd Road, Zhongwu Community, Hangcheng Street, BaoÆan District Shenzhen 518128 CN Other 510(k) Applications for this Company
Contact	Evin Li 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	01/04/2022
Decision Date	04/01/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review