KOKO PFT LTD

Koko PFT Ltd specializes in mechanical spirometers, which are devices used for pulmonary function testing. These instruments measure lung volume and airflow, helping clinicians assess respiratory health and diagnose conditions like asthma or COPD. The company’s focus is on devices designed for clinical and research environments.

Koko PFT Ltd is based in the United States. As a manufacturer operating in this region, its devices must comply with U.S. regulatory requirements, including those set by the FDA for medical devices. The company’s spirometers are subject to the applicable rules governing Class II devices in the U.S.

Koko PFT Ltd’s spirometers are classified as Class II devices by the FDA. This classification indicates that while the devices are not considered low-risk (like Class I), they require special controls to ensure their safety and performance—such as performance standards or post-market surveillance—to mitigate potential risks associated with their use.

Yes, Koko PFT Ltd’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This listing provides transparency on the manufacturer’s products and helps healthcare providers, regulators, and other stakeholders identify and track the devices in compliance with U.S. medical device regulations.