Hyperbaric Chamber Manufacturers

FDA-Cleared Chambers

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

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, Pty. Ltd.

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.

Gulf Coast Hyperbarics, Inc.

Lynn Haven, Florida

HyperTec, Inc.

Olney, Texas

Khrunichev Medical

Khrunichev Space Center, Russia

OxyHeal Health Group

National City, California

Pan-America Hyperbarics, Inc.

Richardson, Texas

Perry Baromedical Corporation

Riviera Beach, Florida

Reimers Systems, Inc.

Lorton, Virginia

Sands Hyperbaric Corporation

San Diego, California

Sechrist Industries, Inc.

Anaheim, 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.

Haux-Life-Support GmbH

Karlsbad, Germany

Hyperbaric Technology (HyTech) B.V.

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 Medical Society.

SOS Hyperlite. Ltd

Douglas, Isle of Man, UK

 Important safety information

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 publish.

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 and conditions.

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.

See Clearance and Approval for more information about how hyperbaric chambers are designated as safe and effective for specific diseases and conditions.

Hyperbaric Chamber Types

There are two basic types of hyperbaric chamber:

Monoplace hyperbaric chambers, in which a single patient receives treatment in an atmosphere of 100% oxygen and

Multiplace hyperbaric chambers, in which one or more patients receive treatment in an atmosphere of normal gas mixes and 100% oxygen is delivered through a mask or hood.

The listed manufacturers build one or both of these types of chamber.

 Learn more about hyperbaric chamber types.

Hyperbaric Chamber Types
US Food and Drug Administration, Center for Devices and Radiological Health. Retrieved 11 August 2011.
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Updated: 14 Aug 2011 11:16 PM
Created: 29 Sep 2010 02:29 PM
By: About the authors »