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Flux Lab Pte. Ltd. d/b/a The Fluxion was cited for failure to register as a medical device manufacturer and for misbranding chest binders sold through their website. The company marketed breast binders (such as "The Fluxion Tank Chest Binder" and "The Fluxion GYM Chest Binder") with claims that they diagnose, treat, or mitigate gender dysphoria and alleviate chest dysphoria, thereby establishing them as medical devices under the Federal Food, Drug, and Cosmetic Act. Despite manufacturing these devices using compression technology from the sports and medical industries, the firm failed to complete the required annual FDA registration under Section 510 of the Act.