FDA 510(k) Application Details - K233485

Device Classification Name	Stimulator, Muscle, Powered   More FDA Info for this Device
510(K) Number	K233485
Device Name	Stimulator, Muscle, Powered
Applicant	Zynex Medical Inc. 9655 Maroon Circle Englewood, CO 80112 US Other 510(k) Applications for this Company
Contact	Thomas Sandgaard Other 510(k) Applications for this Contact
Regulation Number	890.5850   More FDA Info for this Regulation Number
Classification Product Code	IPF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/27/2023
Decision Date	01/26/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review