DONGGUAN CITY SINOSHINE TECHNOLOGY CO., LTD

The company specializes in electric pad whole-body heating systems, which are primarily designed for therapeutic or comfort applications. These include basic heating pads, which provide localized or whole-body warmth for relaxation or medical use.

The company is based in the United States, though its name suggests an origin in Dongguan, China. The location of manufacturing or operations is not specified, but the company’s regulatory listings indicate its primary presence in the US market.

The company’s devices, such as heating pads, are classified as Class II under regulatory frameworks. This classification typically applies to devices with moderate risk, requiring special controls to ensure safety and effectiveness beyond general controls.

Yes, the company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices in the US market, ensuring transparency and traceability for regulatory and clinical purposes.

The Class II classification for devices like heating pads indicates they require additional regulatory oversight beyond basic controls. This ensures that while they are generally considered lower-risk than Class III devices, they still meet strict standards for safety, performance, and labeling to protect users.