FDA 510(k) Application Details - K241678

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K241678
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	Shenzhen Minghuangda Electronics Co., Ltd. Floor 6, Building A, Taixinglong Industrial Park, Hezhou Village, Xixiang Town,Baoan District Shenzhen 518100 CN Other 510(k) Applications for this Company
Contact	Guixiang 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	06/11/2024
Decision Date	09/09/2024
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