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FLAVNT Streetwear, LLC marketed breast binders as medical devices intended to treat gender dysphoria and affect body structure/function through statements on their website, but failed to register as a device manufacturer or list their products with the FDA as required under Section 510 of the Federal Food, Drug, and Cosmetic Act. The company's marketing claims—including descriptions of products designed to "help with gender dysphoria" and language about "dysphoria-easing solutions"—established the binders as devices subject to FDA regulation, yet no evidence of required device registration or listing was found during the FDA's website review.