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O3UV, LLC manufactured autohemotherapy devices (Champion Full Spectrum and EBOO Full Spectrum UV) intended to treat autoimmune diseases, cardiovascular disorders, and respiratory diseases by exposing patient blood to ozone and ultraviolet light before reininfusion. The company violated federal law by distributing these devices without approved Premarket Approval (PMA) applications or Investigational Device Exemption (IDE) authorizations, rendering the products adulterated under section 501(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act. FDA conducted an inspection of the Michigan facility between August 23-31, 2023, and documented that the devices were being sold directly to healthcare practitioners through the company's website nationwide without required regulatory approval.