FDA 510(k) Application Details - K240108

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K240108
Device Name	Electrode, Cutaneous
Applicant	Gymmax Technology Shenzhen Co., Ltd. 5F 4th Bldg., Heping Complex(4th Bldg. Huimingsheng Technology Park)Fuhai Subdistrict, Baoan District Shenzhen 518103 CN Other 510(k) Applications for this Company
Contact	Benson Wang Other 510(k) Applications for this Contact
Regulation Number	882.1320   More FDA Info for this Regulation Number
Classification Product Code	GXY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/16/2024
Decision Date	06/10/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review