Zynex Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
5
Inspections
7
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1874-2014Class IIIF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulatioJanuary 25, 2009

Recent 510(k) Clearances

K-NumberDeviceDate
K233485M-WaveJanuary 26, 2024
K223217Zynex Monitoring System, Model CM-1600June 16, 2023
K191697Cardiac Monitor 1500February 21, 2020
K121820INWAVEAugust 24, 2012
K111279NEXWAVE COMBO MUSCLE STIMULATOR SYSTEMSeptember 20, 2011