Chongqing Xinfeng Medical Instruments Co., Ltd.

The company specialises in non-wearable musculoskeletal infrared phototherapy units, specifically heat lamps. These devices are designed for therapeutic heat application to treat musculoskeletal conditions. Examples include models like the TDP CQ-27, TDP CQ-36, TDP CQ-55, TDP CQ-55A, and the XINFENG HEAT LAMPS, all of which fall under this category.

The company is based in the United States. This location is relevant for regulatory purposes, as their devices are authorised and listed under U.S. regulatory registries, such as the FDA’s 510(k) and UDI systems.

The company’s devices are listed in the FDA’s 510(k) and UDI (Unique Device Identification) registries. These registries are used to track and authorise medical devices in the United States, ensuring compliance with regulatory standards for Class II devices.

The company’s devices are classified as Class II medical devices. This classification is determined by the FDA based on the level of risk associated with the device. Class II devices generally require special controls in addition to general controls to ensure their safety and effectiveness, and they are authorised through processes like the 510(k) pathway.