FDA 510(k) Application Details - K230443

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K230443
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	Jiangxi Royall Smart Technology Co., Ltd. Workshop 3#, Shangyou Lefeng Technology Co., Ltd., Huangbu Town Ganzhou 341200 CN Other 510(k) Applications for this Company
Contact	Shunzhou Yang 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	02/21/2023
Decision Date	05/22/2023
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