ILSEONG Co., Ltd.

ILSEONG Co., Ltd. specializes in pneumatic massagers, which are designed to provide muscle relaxation and therapeutic relief. These devices use controlled air pressure to alleviate tension and improve circulation, typically for use in both home and clinical settings. The most common product category is pneumatic massagers, such as their example device, the VANCOR.

ILSEONG Co., Ltd. is based in the United States. As a manufacturer, they develop their pneumatic massagers in compliance with applicable U.S. regulatory requirements, ensuring their products meet the necessary safety and performance standards for medical devices in that market.

ILSEONG Co., Ltd.’s pneumatic massagers are classified as Class I medical devices under FDA regulations. This classification is typically assigned to devices that pose minimal risk to users, such as pneumatic massagers, which are generally considered low-risk and do not require stringent pre-market approval processes beyond basic registration and listing.

Yes, ILSEONG Co., Ltd.’s pneumatic massagers are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency and traceability for regulatory and market surveillance purposes.