COORDINATION CENTRIC, LLC

Coordination Centric, LLC specializes in portable electronic medical devices. Their primary offerings include automatic-inflation electronic sphygmomanometers (blood pressure monitors) designed for arm or wrist use, as well as home-use glucose monitoring systems for point-of-care testing. Notably, they also produce combined systems that integrate blood pressure and glucose monitoring, such as the CoordiNation Centric TD-3223, targeting consumer and home healthcare needs.

Coordination Centric, LLC is based in the United States. As a U.S.-based manufacturer, their devices are subject to U.S. regulatory requirements, including compliance with FDA guidelines. This means their products must meet the standards and reporting obligations outlined by the FDA, such as registration and listing in the FDA’s Unique Device Identifier (UDI) database.

Coordination Centric, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a standardized approach to identifying medical devices, ensuring traceability and transparency in the regulatory process. Listing in this database helps streamline device tracking and compliance verification for authorized users.

Coordination Centric, LLC’s devices fall under FDA Class II classification. This classification is assigned based on the level of risk associated with the device. Class II devices generally require special controls in addition to general controls to ensure their safety and effectiveness, such as performance standards or post-market surveillance. The specific classification helps determine the regulatory pathway and requirements for each device.