The US Food and Drug Administration (FDA) classifies hyperbaric chambers as Class II medical devices. US federal regulations
govern how hyperbaric chambers are used and what kind of advertising manufacturers and operators of hyperbaric chambers may
Federal and state regulators work to ensure that hyperbaric chambers are safe for human occupancy and operation, in conformity with
standards set by the American Society of Mechanical Engineers (ASME) and the National Fire Protection Association (NFPA).
Like other medical devices, hyperbaric chambers are designed to be operated by trained medical professionals. The National
Board of Diving and Hyperbaric Medical Technology (NBDHMT) credentials Certified Hyperbaric Technologists (CHT) in the US.
Use of a hyperbaric chamber for unapproved or “off-label” diseases and conditions may not be safe or effective.
Operating a hyperbaric chamber in ways other than those approved by the manufacturer, or in violation of federal or
state law, or by unqualified personnel, may result in serious injury or death.
Inflatable devices, so-called “mild hyperbaric“ chambers, are not cleared by the FDA for treatment of any of the
medical conditions approved by the Undersea and Hyperbaric Medical Society.
They cannot provide the pressure or increased oxygen concentration required by the treatment protocols for approved diseases
Use of oxygen concentrators in conjunction with a “mild hyperbaric” chamber may constitute an illegal adulteration
of a medical device and a fire safety hazard.
The Undersea and Hyperbaric Medical Society advises that hyperbaric oxygen therapy should never be administered in the home.
Clearance and Approval
for more information about how hyperbaric chambers are designated as safe and effective for specific diseases and conditions.