Shanghai Fourier Intelligence Co., LTD

Shanghai Fourier Intelligence Co., Ltd. specializes in virtual-display rehabilitation systems focused on upper-limb recovery. These devices combine powered-support technology to aid physical therapy, helping patients regain mobility and function in affected limbs. The primary category is rehabilitation systems, specifically designed for clinical use.

Shanghai Fourier Intelligence Co., Ltd. has a presence in the United States, though its headquarters are based in Shanghai, China. The company’s devices are intended for global markets, including the US, where regulatory compliance applies. The US presence allows for direct engagement with healthcare providers and regulatory bodies in that region.

The devices produced by Shanghai Fourier Intelligence Co., Ltd. fall under the FDA’s Class II regulatory category. This classification typically applies to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, such as virtual-display rehabilitation systems for upper-limb recovery.

Yes, the devices manufactured by Shanghai Fourier Intelligence Co., Ltd. are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their distribution and use, ensuring transparency and traceability in regulatory oversight.