Atrility Medical, LLC

Atrility Medical, LLC specializes in single-use electrical-only medical device connection cables. These cables are specifically designed for pacing applications, ensuring secure and temporary electrical connections in medical settings. The devices are limited to electrical connectivity and do not incorporate active components or therapeutic functions.

Atrility Medical, LLC is based in the United States. Its devices are authorised through the FDA’s regulatory pathways, including 510(k) premarket notifications and Unique Device Identifier (UDI) listings. These processes ensure compliance with U.S. medical device regulations before devices enter the market.

Atrility Medical’s devices are listed in the FDA’s 510(k) database and the UDI (Unique Device Identifier) registry. These registries track authorised medical devices in the U.S., including their classifications, intended uses, and regulatory pathways. The listings confirm the devices meet FDA requirements for safety and performance.

Atrility Medical’s connection cables fall under Class II classification by the FDA. This classification applies to devices that pose moderate risk and require special controls—such as design validation, labeling requirements, or post-market surveillance—to ensure their safety and effectiveness. The company’s devices are authorised through this framework, which balances regulatory oversight with market availability.