HANILMEDICAL CO., LTD.

Hanil Medical Co., Ltd. specializes in two primary categories of devices: electric pad localized-body heating systems, such as the Ceramix mat M1 and Ceramix mat S1, which provide targeted thermal therapy; and freestanding electric massagers, including the HEALAX i Shoulder, designed for muscle relaxation. These products are intended for specific therapeutic applications.

Hanil Medical Co., Ltd. is based in the United States. The company’s location is relevant for understanding regulatory oversight and compliance, as its devices are subject to U.S. medical device regulations.

Hanil Medical Co., Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices under FDA jurisdiction, ensuring traceability and compliance with U.S. regulatory requirements.

Hanil Medical Co., Ltd.’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and may require less stringent regulatory controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway for each device.