Manufacturers of hyperbaric chambers with
FDA clearance for UHMS-approved diseases and conditions
Hospitals, outpatient facilities, and independent hyperbaric clinics treating diseases and conditions for which hyperbaric
oxygen therapy has been approved by the Hyperbaric Oxygen Committee of the
Undersea and Hyperbaric Medical Society
(UHMS) use hard-walled monoplace and multiplace chambers. These chambers are regulated as Class II medical devices by the
US Food and Drug Administration and approved for use with 100% oxygen at 2 ATA (atmospheres of pressure absolute, about
29.39 psi) or higher.
ETC Biomedical Systems has been manufacturing hyperbaric chambers for over 40 years, achieving a number of firsts in chamber
design during that time. ETC chambers are used in hospitals and outpatient facilities throughout the world.
Fink Engineering combines an innovative design approach with state-of-the-art engineering
and fabrication facilities to redefine the form and function of multiplace medical hyperbaric chambers.
Lynn Haven, Florida
Khrunichev Space Center, Russia
National City, California
Perry Baromedical Corporation
Riviera Beach, Florida
San Diego, California
Other manufacturers of hyperbaric chambers
The following manufacturers have not received FDA clearance to market their products in the US. Their chambers conform to
European technical specifications and health and safety standards.
Raamdonksveer, The Netherlands
Manufacturers of hyperbaric stretchers
These new devices are transportable chambers that deliver 100% oxygen at hyperbaric pressures and include integrated oxygen
and power supplies and monitoring and control systems. These manufacturers have received FDA clearance to market their
products to treat the diseases and conditions approved by the Hyperbaric Oxygen Committee of the Undersea and Hyperbaric
Douglas, Isle of Man, UK
Manufacturers of portable "mild hyperbaric" chambers
Mild HBOT is administered in inflatable bags that operate with room air (21% oxygen) at slightly increased pressure
(< 1.5 ATA). These manufacturers of mild hyperbaric bags have received FDA clearance to market their devices for the treatment of
Acute Mountain Sickness(AMS) only.
Treatment of AMS with a portable hyperbaric device simulates conditions at lower altitudes (where the atmospheric
pressure is higher) when bad weather or other factors make climbing down dangerous or impossible.
Mild hyperbaric devices are not
FDA-cleared for the
treatment of any
diseases and conditions.
The UHMS warns that hyperbaric treatment should not be self-administered or administered by nonprofessionals in the home.
The National Board of Diving and Hyperbaric Medical Technology
(NBDHMT), the certifying authority for hyperbaric technologists and nurses, has stated that "the design, fabrication and common use of portable,
fabric, low-pressure (operating at pressures of no greater than 1.4 ATA) hyperbaric chambers is inconsistent with recognized and prevailing
safety codes and standards."
Read the full NBDHMT statement »
Some of these companies or their dealers may also sell oxygen concentrators. Oxygen concentrators are not intended for use
with hyperbaric devices and such misuse may create a safety hazard.
Use of oxygen concentrators with mild hyperbaric devices has not been cleared by the FDA.
Use of an oxygen concentrator with mild hyperbaric devices is illegal in most US states.
Your insurance may not cover property damage, injury, or death resulting from unlawful use of an oxygen concentrator
in combination with these devices.
Important Note: The following companies, or other companies that resell or use the products made by these companies,
may make claims that are not in compliance with FDA labeling regulations. HyperbaricLink has no association with these companies and
expressly disclaims any connection to the statements made by these companies.
Freeport, New York
(Registered Agent for Certec, Sourcieux Les Mines, France)
FDA Clearance and UHMS Approval »
Hyperbaric Chamber Types »
US Food and Drug Administration
Undersea and Hyperbaric Medical Society
American Society of Mechanical Engineers
National Fire Protection Association
Important information about
hyperbaric chamber safety regulations
The US Food and Drug Administration (FDA) regulates the marketing of hyperbaric chambers as Class II medical devices. 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 and 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.
Other products and services for hyperbaric oxygen therapy
Manufacturers and Distributors of HBOT Accessories and Systems »
Treatment Center Management, Operations, and Consulting Services »