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Zynex submits FDA application for next generation NMES device
The Fly

Zynex submits FDA application for next generation NMES device

Zynex announced that it has submitted a 510(k) application to the U.S. Food and Drug Administration, FDA, for the M-Wave Neuromuscular Electrical Stimulation, NMES, device. The M-Wave is set to replace its predecessor, the E-Wave, which has been fundamental in NMES treatments across the U.S. since 1998. The E-Wave has helped over 17,500 patients with muscle-related issues such as drop-foot, quad rehabilitation, shoulder subluxation, and hand rehabilitation. “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 Thomas Sandgaard, CEO at Zynex Medical. “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 customizable NMES treatments in clinical and home settings.”

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