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ShapeShifter Apparel, LLC failed to register as a medical device manufacturer and misbranded breast binders by making therapeutic claims on their website linking the products to treatment of gender dysphoria and mitigation of dysphoria-related symptoms. The FDA determined that statements such as "Chest Binding 101… What Sorta Reasons? Gender dysphoria" and references to compression amounts based on "dysphoria level" caused the products to meet the definition of medical devices under Section 201(h) of the Federal Food, Drug, and Cosmetic Act. The company was also found to be manufacturing devices (described as "custom-sized, hand-made, made-to-order") without complying with Section 510 requirements for annual FDA establishment registration and device listing.