FDA 510(k) Application Details - K213835

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K213835
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	Shenzhen Jian feng Electronic Technology Co. Ltd. 902,903 Jialingyu Industrial Building, Da Pu Road Houting Village, Shajing Town, Baoan District Shenzhen 518104 CN Other 510(k) Applications for this Company
Contact	Feng Wen 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	12/09/2021
Decision Date	03/03/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review