FDA 510(k) Application Details - K212377

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K212377
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	Ningbo MedKinetic Medical Device Co., Ltd. Lushan West Road 167-8, Ningbo Free Trade Zone(South) Ningbo 315806 CN Other 510(k) Applications for this Company
Contact	Zhang Wei 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	08/02/2021
Decision Date	04/15/2022
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