Koko, LLC

Koko, LLC specializes in pulmonary function analysis systems for adult patients. These include whole-body plethysmographs, which are used to measure key lung function metrics such as airflow, lung volumes, and airway resistance. These measurements help healthcare providers assess respiratory health and diagnose conditions like asthma or chronic obstructive pulmonary disease (COPD).

Koko, LLC is based in the United States. Its devices are regulated in the U.S. under FDA guidelines, where they fall under the jurisdiction of the agency’s medical device classification system.

Koko, LLC’s devices are classified as Class II medical devices by the FDA. This classification typically applies to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, such as pulmonary function analysis systems.

Yes, Koko, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This database helps track and identify medical devices in the U.S., ensuring transparency and traceability for regulatory and market surveillance purposes.