FDA 510(k) Application Details - K221199

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K221199
Device Name	Electrode, Cutaneous
Applicant	Green Island International TCM Group Limited Flat 566 7/F, Kiu Kin Mansion, 566-568 Nathan Road, Kowloon, Hongkong Hongkong 999077 CN Other 510(k) Applications for this Company
Contact	Zhang Shuai 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	04/26/2022
Decision Date	12/19/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review