O3UV, LLC

Warning LetterOpen

Timothy Lowe Owner O3UV, LLC 11968 Sweetwater Drive Grand Ledge , MI 48837-8101 United StatesFEI 3027918571Issued Jul 7, 2025Center for Biologics Evaluation and Research (CBER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3027918571.

Letter Details

Firm: O3UV, LLC
Location: Timothy Lowe Owner O3UV, LLC 11968 Sweetwater Drive Grand Ledge , MI 48837-8101 United States
FEI Number: 3027918571
Country: United States
Issue Date: July 07, 2025
Issuing Office: Center for Biologics Evaluation and Research (CBER)
Product Type: Medical Devices
Status: Open

Summary

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.