Class II Medical Device & FDA Disclaimer

Hormetix offers hyperbaric oxygen chambers, such as those from OxyRevo and MACY-PAN, operating at 1.3-1.5 ATA. These are classified by the U.S. Food and Drug Administration (FDA) as Class II medical devices under 21 CFR 868.5470. They are cleared for specific medical uses—like decompression sickness and certain wounds (see FDA’s July 2021 clearance list)—and for those FDA-approved conditions, a prescription from a licensed healthcare provider is required in the United States. However, off-label use is legally permitted without a prescription, though the FDA has not evaluated its safety or efficacy for such purposes. We strongly recommend consulting a qualified medical professional before any use to ensure it’s appropriate for your needs. Hormetix does not claim HBOT cures unapproved conditions (e.g., cancer, autism). Chambers are shipped unopened from manufacturers; setup and operation are your responsibility—please follow all manuals and instructions provided by Hormetix and/or the manufacturer. For questions about usage or local regulations, contact your healthcare provider or relevant authorities. Hormetix complies with FDA marketing guidelines but is not liable for misuse or adverse events.