Hyperbaric Chamber Criteria

These questions ensure the product meets local and international safety standards.

Can you provide the FDA 510(k) letter for this chamber?

• Why: This gives buyers confidence that the device has been evaluated for safe clinical use and meets engineering and safety standards under U.S. law. For clinicians, this is necessary for applying for facility accreditation or getting malpractice insurance coverage.
• Common misconceptions: FDA-registered ≠ FDA-cleared. Registration only means the company told the FDA it exists. It does not mean the device is cleared or evaluated to be legally offered within the USA.

For hard shell constructed chambers:Is the chamber ASME PVHO-1 stamped and serialized individually? Do you have the documents to support? (GR-1 Form)

• Why: This validates the structural integrity, design safety, and compliance of a pressure vessel for human occupancy under pressure. Without this, the chamber’s safety under pressure cannot be guaranteed.
• This stamp certifies that the hyperbaric chamber is designed using recognized engineering principles, is manufactured by an ASME-accredited facility, and has passed required material, weld and pressure testing from a third-party engineer.
• If the company cannot produce a GR-1 form and does not have a PVHO-1 stamp: (1) the vessel was not built to any recognized standard, (2) safety testing was not done or not verified by an independent inspector, and (3) the chamber may be illegal for clinical or commercial use in the United States.

Is the manufacturer ISO 13485 certified?

• Why: This is an international standard that certifies the manufacturer for meeting  the quality management system (QMS) requirements for the design, production, installation, and servicing of medical devices.

Are the electrical components UL certified?

• Why: Ensures the device is certified for electrical and fire safety compliance.

Materials, Construction & Testing

Understanding materials used and their testing reveals long-term durability, health safety, and fire protection.

• Have flammability tests been performed on all internal components (fabrics, cushions)? Can you provide reports?

Operation, Safety & Redundancy

These address day-to-day usability and emergency backup features.

• Is there a mechanical override for all digital control systems (pressure control, oxygen delivery, door locks)?
• Can the user inside the chamber communicate with someone outside (e.g., intercom or visual signals)?

Service, Maintenance, and Support

This ensures you won’t be left alone post-purchase.

• What is the expected lifespan of the chamber (under normal use)?
• What are the preventative maintenance requirements, and are they user-performable or factory-required?
• How quickly can parts (windows, valves, digital displays) be shipped and replaced if something fails?
• Is there a loaner program or mobile service option for repairs during downtime?
• Do you offer training on safe operation, emergency procedures, and basic troubleshooting?

Warranty & Insurance Considerations

Understand your coverage and liability.

• How long is the warranty and what does it cover?

Final Logistics

Wrap-up questions before purchase.

• How is the chamber shipped?
• Is professional installation required or offered?