Zynex, Inc. Submits FDA Application for Its NMES Device
November 13, 2023 at 07:45 pm IST
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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 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.
The E-Wave has been the most powerful and versatile muscle stimulation device on the market for over two decades, and the M-Wave will be a more modern design with the same versatility and ease of use. The M-Wave is designed to improve the way patients manage their neuromuscular conditions. With advanced features and a user-friendly design, the M-Wave allows patients to be treated in a clinical or home setting with ease.
The compact and lightweight design of the M-Wave ensures portability and easy integration into patients' recovery routines. The 510(k) application submission represents a significant milestone in Zynex Medical's commitment to delivering cutting-edge medical devices. This application demonstrates the company's dedication to ensuring that patients have access to the latest innovations in medical technology.
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.