Coapt, LLC

Coapt, LLC specializes in reusable myoelectric hand prostheses and related components. Their products include complete control systems for prosthetic limbs, such as amplifiers, controllers, and communication modules, as well as standalone analytical non-scalp cutaneous electrodes like the ControlSeal Electrode Domes. These electrodes detect muscle signals to enable limb movement, catering to users requiring upper-limb prosthetics with customizable functionality.

Coapt, LLC is headquartered in the United States. This location influences its regulatory obligations, as its devices must comply with both U.S. and EU requirements when marketed in those regions. For example, their devices are listed in the FDA’s UDI database for U.S. regulatory tracking and in the EU’s euamed registry, ensuring transparency and traceability under respective medical device regulations.

Coapt, LLC’s devices are listed in two key registries: the EU’s euamed database and the U.S. FDA’s Unique Device Identifier (UDI) system. Listing in these registries is critical because it ensures compliance with regulatory requirements, facilitates device traceability for healthcare providers and authorities, and provides transparency on authorized products. This helps users, clinicians, and regulators verify the legitimacy and classification of the devices.

Coapt, LLC’s devices are classified under both Class I and Class II categories, depending on their specific function and associated risk. Class I devices generally pose minimal risk and may require fewer regulatory controls, while Class II devices involve a higher level of risk—such as those involving patient monitoring or signal processing for prosthetics—and require stricter premarket evaluations to ensure safety and effectiveness. The classification determines the regulatory pathway and scrutiny each device undergoes.

Coapt’s analytical non-scalp cutaneous electrodes, such as the ControlSeal Electrode Domes, are designed to detect myoelectric signals from muscles beneath the skin. These electrodes interface with prosthetic limbs, translating muscle contractions into control signals for artificial limb movement. By providing a reusable and customizable interface, they enable users to operate myoelectric hand prostheses with greater precision and adaptability, addressing the needs of individuals with upper-limb amputations.