FDA 510(k) Application Details - K231648

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K231648
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	Shenzhen Yiran Intelligent Co., Ltd Floor 6, No. 531 Nanpu Road, Huangpu Community, Xinqiao Street, Bao'an District, Shenzhen 518125 CN Other 510(k) Applications for this Company
Contact	Fengqing 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	06/05/2023
Decision Date	03/01/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review