Loading…
GenderBender LLC was cited for selling breast binders as medical devices without proper FDA registration and listing, and for misbranding the products through claims that they treat medical conditions like gynecomastia and aid post-surgical recovery. The company failed to register as a device manufacturer as required under section 510 of the Federal Food, Drug, and Cosmetic Act and made therapeutic claims on its website that classified the binders as medical devices rather than consumer apparel. The FDA determined that statements describing the binders' use for compression after surgery and treatment of chest conditions constituted intended use claims that brought the products under FDA jurisdiction as Class I or II medical devices.