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Trans-Missie B.V. (operating as UNTAG) was cited for marketing breast binders as medical devices without proper FDA registration and listing, and for misbranding. The company's website contained claims that the binders were intended to treat gender dysphoria, reduce body dysphoria, and improve mental health outcomes—statements that caused the products to meet the legal definition of medical devices under the Federal Food, Drug, and Cosmetic Act. The FDA determined these therapeutic and body-function claims, combined with the company's failure to register as a device manufacturer, constituted violations of device regulation requirements.