FDA 510(k) Application Details - K212618

Device Classification Name	Stimulator, Nerve, Transcutaneous, For Pain Relief   More FDA Info for this Device
510(K) Number	K212618
Device Name	Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant	Fast Track Technologies, Inc. 4400 MacArther Blvd., Ste. 900 Newport Beach, CA 92660 US Other 510(k) Applications for this Company
Contact	Geoffrey Pfeifer Other 510(k) Applications for this Contact
Regulation Number	882.5890   More FDA Info for this Regulation Number
Classification Product Code	GZJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/18/2021
Decision Date	09/14/2022
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