Zynex has submitted a 510(k) application seeking approval from the US Food and Drug Administration (FDA) for its M-Wave Neuromuscular Electrical Stimulation (NMES) device.
The M-Wave is intended to replace its predecessor, the E-Wave muscle stimulation device, which has been fundamental in NMES treatments across the country.
The E-Wave has been considered a significant device on the market for more than two decades, while the M-Wave has a more modern design with the same ease of use.
Zynex’s new device aims to improve the way individuals handle their neuromuscular conditions.
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It comes with a user-friendly design and advanced features, enabling it to treat patients in a clinical or home setting.
Furthermore, the device’s compact and lightweight design enables portability and easy integration into the recovery routines of the patient.
“We are excited to introduce the M-Wave, a device that showcases our ongoing commitment to improving the lives of patients dealing with neuromuscular conditions,” said Zynex Medical CEO Thomas Sandgaard.
“The M-Wave will be another game-changer, providing a more effective and user-friendly treatment option for patients and a valuable tool for healthcare professionals.
“I believe that this next-generation device will be able to build upon the need for customisable NMES treatments in clinical and home settings.”
Zynex is involved in the development, manufacturing, marketing and sale of medical devices for pain management and rehabilitation.
The company also offers non-invasive fluid, sepsis and laser-based pulse oximetry monitoring systems for use in hospitals.
