FDA 510(k) Application Details - K230829

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K230829
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	Chongqing Rob Linka Science And Technology Co., Ltd. B3-2, Liangjiang Health Science And Technology City, No. 2 Yuekang Road, Fuxing Street, Beibei D Chongqing 400700 CN Other 510(k) Applications for this Company
Contact	Yixuan Li 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	03/27/2023
Decision Date	04/26/2023
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	Y
Expedited Review