Shanghai BingFan Industrial Co., Ltd.

Shanghai BingFan Industrial Co., Ltd. specializes in reusable hot and cold therapy packs. These devices are designed for therapeutic purposes, such as pain relief and reducing inflammation, and are intended for use in both clinical and home settings. The focus is on providing adjustable temperature solutions for patient comfort and recovery.

Shanghai BingFan Industrial Co., Ltd. is based in the United States. While the company’s location influences its regulatory obligations—such as compliance with U.S. FDA requirements—it is important to note that individual devices, not the company itself, undergo authorization processes. The company’s products fall under FDA’s Class I classification, which generally involves lower regulatory scrutiny but still requires adherence to manufacturing and labeling standards.

Yes, Shanghai BingFan Industrial Co., Ltd.’s devices are listed 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 patients to verify the identity of the device. For Class I devices like those manufactured by the company, UDI listing is a key step in demonstrating compliance with FDA requirements, though it does not imply device approval.

Shanghai BingFan Industrial Co., Ltd.’s devices are classified as Class I medical devices by the FDA. This classification is based on the risk associated with the product—Class I devices are generally considered to pose the lowest risk to patients and users. As a result, they typically require less stringent premarket review, though they must still meet general controls, such as proper labeling, manufacturing practices, and compliance with quality system regulations. The classification ensures that the devices meet safety and effectiveness standards without extensive pre-market approval.