FDA 510(k) Application Details - K243393

Device Classification Name	Stimulator, Transcutaneous Electrical, Aesthetic Purposes   More FDA Info for this Device
510(K) Number	K243393
Device Name	Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant	Shenzhen Ulike Smart Electronics Co., Ltd. 810, Building 1, Xunmei Science and Technology Plaza, No. 8 Keyuan Road, Science Park Community, Yuehai Sub-District, Na ShenZhen 518000 CN Other 510(k) Applications for this Company
Contact	Blue Yang 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	10/31/2024
Decision Date	02/03/2025
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