FDA 510(k) Application Details - K241228

Device Classification Name	Stimulator, Nerve, Transcutaneous, For Pain Relief   More FDA Info for this Device
510(K) Number	K241228
Device Name	Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant	Zynex Medical Officer 9655 Maroon Circle Englewood, CO 80112 US Other 510(k) Applications for this Company
Contact	Sandgaard Thomas 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	05/02/2024
Decision Date	08/27/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review