FDA Disclaimer

The products and the claims made about specific items including hyperbaric chambers throughout this website have not been evaluated by MorelliMedical.com or the United States Food and Drug Administration (FDA) and neither are approved by the same. These products are not intended to diagnose, treat, cure or prevent disease. The information provided on this site is for informational purposes only and is not intended as a substitute for advice from your physician or other healthcare professional or any information contained on or in any product label or packaging. Individual results may vary. You should not use the information on this site for diagnosis or treatment of any health problem or for prescription of any medication or other treatment. You should always consult with a healthcare professional before starting any regimen, diet, exercise program or supplementation or before taking any medication or using any products on this website or in any event you might have a health issue whether known or unknown.

Hyperbaric Chambers

Morelli Medical offers hyperbaric oxygen chambers from trusted brands like OxyRevo and MACY-PAN, operating at pressures between 1.3 to 1.5 ATA. These units are classified by the U.S. Food and Drug Administration (FDA) as Class II medical devices under 21 CFR 868.5470. They are FDA-cleared for specific medical conditions—such as decompression sickness and certain non-healing wounds (see FDA’s July 2021 clearance list). For these approved uses, a prescription from a licensed healthcare provider is required in the United States.

That said, off-label use is legally allowed without a prescription. However, the FDA has not evaluated the safety or effectiveness of HBOT for non-approved conditions. We strongly recommend consulting a qualified medical professional before use to determine whether hyperbaric oxygen therapy is right for you.

Morelli Medical does not make claims that HBOT can cure unapproved conditions such as cancer, autism, or others. Chambers are shipped brand new and unopened directly from the manufacturer. Setup and operation are your responsibility—please carefully follow all instructions and manuals provided by Morelli Medical and/or the manufacturer.
If you have questions about usage or local regulations, please speak with a healthcare provider or your local health authorities. Morelli Medical complies with FDA marketing guidelines and is not liable for misuse or adverse outcomes.