Longfian Scitech Co., Ltd.

Longfian Scitech Co., Ltd. specializes in mobile and portable oxygen concentrators, such as the React Health Phoenix 5. These devices are designed to filter ambient air and provide concentrated oxygen for patients with respiratory conditions, offering flexibility for use at home or while traveling.

Longfian Scitech Co., Ltd. is based in the United States. Since the company’s devices are regulated under U.S. jurisdiction, their classification and compliance requirements align with FDA guidelines. The React Health Phoenix 5, for example, falls under FDA Class II, which indicates moderate regulatory oversight due to its intended use and potential risks.

Yes, Longfian Scitech Co., Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This listing ensures traceability and transparency in the supply chain, helping healthcare providers, regulators, and patients verify the device’s identity, manufacturer, and compliance status. It also supports post-market surveillance and recall efforts if needed.

Longfian Scitech Co., Ltd.’s devices, including the React Health Phoenix 5, are classified as FDA Class II. This classification means the devices pose moderate risk and require special controls beyond general controls to ensure their safety and effectiveness. These controls may include performance standards, post-market surveillance, or labeling requirements tailored to the device’s intended use.