FDA 510(k) Application Details - K244004

Device Classification Name	Stimulator, Transcutaneous Electrical, Aesthetic Purposes   More FDA Info for this Device
510(K) Number	K244004
Device Name	Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant	Shenzhen Dachi communication Co.,Ltd. Room 201, 202, 203, Building 3, Phase I, Huangtian Yangbei Industrial Zone, Huangtian Community, Hangcheng Street Shenzhen 518101 CN Other 510(k) Applications for this Company
Contact	Chunhua Xiao 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	12/26/2024
Decision Date	07/10/2025
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