Shanghai GK Industrial Co., Ltd.

Shanghai GK Industrial Co., Ltd. specializes in electric pad systems designed for localized-body heating. Their primary product category is portable, adjustable heating pads, some of which also incorporate aromatherapy functionality. These devices are intended for targeted heat therapy applications.

Shanghai GK Industrial Co., Ltd. has a US-based presence, which means its devices are subject to FDA regulations. The company’s products are classified as Class II medical devices, indicating a moderate level of risk and regulatory oversight, requiring compliance with specific FDA requirements for safety and performance.

Yes, Shanghai GK Industrial Co., Ltd.’s devices are included 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.

Shanghai GK Industrial Co., Ltd.’s devices fall under Class II classification according to FDA regulations. This classification is assigned based on the level of risk associated with the device—Class II devices pose a moderate risk and require special controls in addition to general controls to ensure their safety and effectiveness.