Zynex, Inc. Submits FDA Application for its Next Generation Fluid and Blood Volume Monitor
January 03, 2022 at 09:00 am EST
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Zynex, Inc. announced that it has submitted a 510(k) application to the U.S. Food and Drug Administration ("FDA") for the CM-1600, its next generation fluid monitoring system. The Zynex Fluid Monitoring System (CM-1500) is a 100% non-invasive solution for monitoring fluid changes throughout patient care environments. Patient fluid status is determined using an algorithm that combines the trends of several physiological parameters to generate a single Relative IndexTM (RI) value, allowing for fast interpretation of changes in fluid volume.
Zynex, Inc. develops, manufactures, markets and sells medical devices used for pain management and rehabilitation, as well as non-invasive fluid, sepsis and laser-based pulse oximetry monitoring systems for use in hospitals. The Companyâs devices are intended for pain management to reduce reliance on medications and provide rehabilitation and increased mobility through the utilization of non-invasive muscle stimulation, electromyography technology, interferential current, neuromuscular electrical stimulation and transcutaneous electrical nerve stimulation. The Companyâs products include Zynex Medical Products, which includes NexWave, NeuroMove, InWave, E-Wave and M-Wave; Private Labeled Supplies, which includes Electrodes and Batteries; Distributed Complementary, which includes Comfortrac/Saunders, JetStream/Pain Management Technologies, LSO Back Braces and Bracing, and Zynex Monitoring Solutions Products, which includes CM-1500, CM-1600, NiCO CO-Oximeter and HemeOx tHb Oximeter.
ZYNEX, INC. 
