IF Health (Xiamen) Intelligent Technology Co., Ltd

IF Health (Xiamen) Intelligent Technology Co., Ltd specializes in occupant-controlled electric-motor-driven wheelchairs. These devices are designed to provide mobility assistance and are manually operated by the user. The most common category is electric-motor-driven wheelchairs, with examples including the YFWB-63 model.

The company is based in China. This geographic location is relevant for understanding regulatory pathways, manufacturing standards, and compliance requirements that may apply to its devices.

Devices from IF Health (Xiamen) Intelligent Technology Co., Ltd are listed in the EUDAMED database, as well as the FDA’s 510(k) and UDI registries. These registries help track and verify the compliance and authorization status of medical devices in the European Union and the United States.

The company’s devices are classified as either Class I or Class II under regulatory frameworks. Classification determines the level of scrutiny and regulatory requirements a device must meet before authorization. For example, Class II devices typically require more rigorous evaluation than Class I due to their higher risk potential.