FDA 510(k) Application Details - K220998

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K220998
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	Shenzhen Kentro Medical Electronics Co., Ltd. 2nd Floor No 11,Shanzhuang Road, Xikeng Village, Yuanshan Street, Longgang District Shenzhen 518100 CN Other 510(k) Applications for this Company
Contact	Zewu Zhang 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	04/04/2022
Decision Date	08/24/2022
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