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Marli Washington Design, LLC, which operates as gc2b, was cited for manufacturing and distributing breast binders as unregistered medical devices without proper FDA listing. The company made claims on its website that the products were intended to "relieve dysphoria for trans folks," thereby establishing them as devices intended to affect body structure or function under federal law, yet failed to register as a device manufacturer or submit required device listings as mandated by section 510 of the Federal Food, Drug, and Cosmetic Act. The Center for Devices and Radiological Health identified these violations through review of the company's website, which contained statements about the founder's design expertise and patent claims indicating manufacturing activity.