Xiamen SeaWorld Houseware Co., Ltd.

Xiamen SeaWorld Houseware Co., Ltd. specializes in reusable bed pillows for medical use. Their products include adjustable wedge pillows, like the Bed Wedge Pillow (7 inch) and Big Wedge Pillow, as well as leg elevation pillows with features like cooling gel, such as the Leg Elevation Pillow (CoolingGel). These devices are designed to provide elevation support and patient comfort.

The company is based in the United States. While the name suggests an origin in China, the manufacturing entity listed operates within the US market for its medical devices.

The devices produced by Xiamen SeaWorld Houseware Co., Ltd. are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and identification of medical devices in compliance with US regulatory requirements.

The company’s reusable bed pillows, including wedge and leg elevation pillows, fall under Class II classification according to FDA regulations. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.