FDA 510(k) Application Details - K243430

Device Classification Name	Stimulator, Transcutaneous Electrical, Aesthetic Purposes   More FDA Info for this Device
510(K) Number	K243430
Device Name	Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant	Shenzhen Aozemei Technology Co. Ltd 3/F, Building 9, Tianfu 'an Industrial Park, lezhujiao Huangmabu Community, Hangcheng Street, Baoan District Shenzhen 518128 CN Other 510(k) Applications for this Company
Contact	Zemin Wu Other 510(k) Applications for this Contact
Regulation Number	882.5890   More FDA Info for this Regulation Number
Classification Product Code	NFO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/05/2024
Decision Date	12/19/2024
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