Hyperbaric Safety
Essential questions to ask before purchasing a hyperbaric chamber, provided by the International Hyperbaric Association to ensure the device you're using is safe and approved for use.
Endorsed by the IHA
These safety questions have been provided by the International Hyperbaric Association to help buyers make informed, safe purchasing decisions.
Before You Buy
Questions Every Buyer Should Ask
Whether you're a physician, clinic owner, or individual buyer, these questions will help you evaluate any hyperbaric chamber manufacturer.
FDA 510(k) Clearance
Can you provide the FDA 510(k) letter for this chamber?
Why this matters: 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.
FDA-registered does not mean 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.
Hard Shell Chamber Standards (ASME PVHO-1)
Is the chamber ASME PVHO-1 stamped and serialized individually? Do you have the documents to support? (GR-1 Form)
Why this matters: 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: the vessel was not built to any recognized standard, safety testing was not done or not verified by an independent inspector, and the chamber may be illegal for clinical or commercial use in the United States.
ISO 13485 Certification
Is the manufacturer ISO 13485 certified?
Why this matters: 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.
Electrical Safety
Are the electrical components UL certified?
Why this matters: Ensures the device is certified for electrical and fire safety compliance.
Materials, Construction & Testing
Have flammability tests been performed on all internal components (fabrics, cushions)? Can you provide reports?
Why this matters: Understanding materials used and their testing reveals long-term durability, health safety, and fire protection.
Operation, Safety & Redundancy
Is there a mechanical override for all digital control systems?
Why this matters: Mechanical overrides for pressure control, oxygen delivery, and door locks ensure safe operation even in the event of electronic failure.
- 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 & Support
What ongoing support does the manufacturer provide?
Why this matters: Reliable service and support infrastructure is critical for long-term operation, patient safety, and minimizing equipment downtime.
- 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
How long is the warranty and what does it cover?
Why this matters: Warranty terms reflect the manufacturer's confidence in their product and protect your investment against defects and unexpected failures.
Logistics
How is the chamber shipped and installed?
Why this matters: Understanding shipping methods and installation requirements ensures proper setup and prevents damage during transit.
- How is the chamber shipped?
- Is professional installation required or offered?
Our Commitment
OxyHealth Meets Every Standard
We don't just meet the minimum. OxyHealth exceeds every safety standard listed above, backed by nearly three decades of engineering excellence.
FDA 510(k)-Cleared
Legally evaluated and cleared for clinical use in the United States
ASME PVHO-1 Certified
Every hard shell chamber stamped and serialized with full GR-1 documentation
ISO 13485 Certified
Quality management system certified for medical device manufacturing
UL Certified
All electrical components independently certified for safety compliance
Have Safety Questions?
Our team is ready to provide documentation for any safety standard, certification, or compliance question. We have nothing to hide.