FDA clears electrical muscle stimulator suit for neuromuscular injuries, disease
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The FDA has granted 510(k) clearance to Neuro20 Technologies for its Neuro20 Pro System, a wearable whole-body electrical muscle stimulator suit, software and operating system for neuromuscular injuries and disease.
According to a company release, the system involuntarily stimulates 42 muscles independently or via co-contraction using large-contoured electrodes that cover maximum motor neuron activation. The Neuro20 Pro System has four programs and nine sub-modes for strength and recovery, including the company’s proprietary Patterned Electrical Muscle Stimulation program that involuntarily contracts muscles while a user attempts to override the movement.
FDA clearance allows the system to be used for muscle re-education, increasing blood circulation, maintaining or improving range of motion, relaxing muscle spasms, and reduction or prevention of muscle atrophy, the company stated.
“FDA clearance of our Neuro20 PRO System to treat neuromuscular injury and disease is a significant milestone for Neuro20 Technologies as we prepare to educate the market about the benefits of this technological advancement,” Dennis M. Schmitt, CEO of Neuro20 Technologies, said in the release. “We are excited to reframe the possibilities in this field by working with providers to demonstrate this new, efficient technology.”
According to the release, results show electrical stimulation can provide up to 20% increase in maximum voluntary muscle contraction, up to 30% vascular dilation and an increase in brain-derived neurotrophic factor between 18% and 30%, depending on gene expression.
“Neuro20 Technologies has solved the greatest roadblock in rehabilitation: correcting old habits that were formed in response to old injuries,” Davis W. Brockenshire, DC, owner of Innovative Health Solutions in Michigan, said in the release. “The ability to retrain corrective movement patterns without injury or exhaustion allows the client to achieve a freedom of performance otherwise unattainable.”