FDA 510(k) Application Details - K212184

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K212184
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	Changsha Yuwen Medical Equipment Co.,Ltd. Room 2404, Kairui Building, No. 245 Laodong West Road, Tianxin District, Changsha, Hunan. Changsha 410004 CN Other 510(k) Applications for this Company
Contact	Dahui Chen 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	07/13/2021
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