A: All bioelectric impedance analysis (BIA) scales sold by Tanita have been cleared by FDA for sale in the US. BIA scales are medical devices that are regulated by the United States Food, Drug and Cosmetic Act, Section 510(k). This includes review and clearing an application for a BIA scale prior to its sale to ensure the scale is safe and effective. The FDA also subjects Tanita to periodic inspections to make sure that we comply with their manufacturing regulations as well. Other scale manufacturers bypass this clearance process, Tanita does not compromise, your confidence is our priority.