FDA 510(k) Application Details - K222863

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K222863
Device Name	Electrode, Cutaneous
Applicant	Tone-A-Matic International Inc. 145 Traders East, Unit 18 Mississauga L5Z-3L3 CA Other 510(k) Applications for this Company
Contact	Manuel Chuck 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	09/22/2022
Decision Date	02/01/2023
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