Coapt LLC, the only provider of commercially available, intuitive control systems for advanced prosthetic arms, has obtained the U.S. Food and Drug Administration’s (FDA) Class II medical device clearance for its COMPLETE CONTROL System. It is the first and only myoelectric pattern recognition system to be cleared for marketing in the United States by the FDA. This clearance indicates the device’s high level of safety and effectiveness.
This FDA clearance is another first from the leading biomedical engineering firm. Coapt currently brings cutting-edge technology to some of the more than 100,000 upper-limb amputees and those with congenital limb differences in the U.S., allowing them to participate in work and daily routines with ease. Its plug-and-play hardware seamlessly integrates with every major powered prosthetic arm component, making it simple for users – from utility workers to farmers to lawyers – to regain their independence with minimal training time.
“We’re constantly pushing forward the limits of technology to allow our users better, safer, more reliable control of their upper-limb prostheses,” states Blair Lock, co-founder and CEO of Coapt. “The FDA Class II medical device clearance is another indication that our product is a high-quality solution for advanced prosthetic arms. As an industry leader in the field of intuitive control, Coapt never stops innovating.”
Coapt’s COMPLETE CONTROL System uses groundbreaking pattern recognition technology to decode the electrical signals that a user’s remaining muscles make as the brain sends information to the absent limb, enabling the user to move the prosthesis intuitively. This gives the user unprecedented limb control, far beyond what is possible with existing prostheses alone, which often feel unnatural and uncomfortable to control.