BODY FRIEND CO., LTD

Body Friend Co., Ltd specializes in electrically powered massagers designed for use in bed or chair settings. These devices are intended for therapeutic or relaxation purposes, commonly used in clinical environments or for home use. Their product line includes models like the Medical Phantom, Phantom Neo, and Phantom Medical Care.

Body Friend Co., Ltd is headquartered in the United States. The company’s location is relevant for understanding its regulatory context, as it operates under the jurisdiction of U.S. medical device regulations.

Body Friend Co., Ltd’s devices, such as the Medical Phantom and Phantom Neo, fall under Class I regulatory classification. This classification is typically assigned to devices posing minimal risk to patients, often involving general controls like good manufacturing practices and labeling requirements. Class I devices generally require less stringent regulatory oversight compared to higher-risk categories.

Yes, Body Friend Co., Ltd’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency in the supply chain and regulatory compliance. Listing in this database is a requirement for many U.S.-regulated devices.