XIAMEN WORLD GEAR SPORTS GOODS CO., LTD

The company specializes in manual mobile patient lifting systems, which are designed to assist caregivers in safely transferring patients with limited mobility or strength. These devices are intended for use in both clinical and home settings, such as hospitals, nursing homes, or patient residences.

The company is headquartered in the United States. This location may influence regulatory compliance and distribution channels for its devices.

The company’s devices fall under Class I classification, which typically means they pose minimal risk and are subject to the lowest level of regulatory oversight. This classification is based on the intended use of the devices as manual patient lifting systems, which are considered low-risk due to their straightforward mechanical function and lack of advanced technology.

Yes, the company’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This listing helps ensure traceability and transparency in the supply chain, allowing healthcare providers, regulators, and other stakeholders to identify and verify the devices.