Our story
Why OxyHealth
Since 1997, OxyHealth has designed, built and supported more than 19,000 hyperbaric chambers in the USA. Every one began with a conversation, and every one still has a team behind it.
One partner, from your first call through years of ownership.
Owning a hyperbaric chamber is not a single purchase. It is a relationship, and the line below never changes hands.
Chapter 1
It starts with a conversation.
A hyperbaric specialist learns what you want, the space you have, and whether the chamber is for your home or your practice. Then they walk you through the differences between models so the choice is yours, made with the full picture.
Chapter 2
Built for you, in the USA.
Your chamber is designed, manufactured and supported in the USA under an ISO 13485 certified quality management system, with medical-grade materials and a compressor engineered specifically for hyperbaric use.
Chapter 3
Proven before it ships.
OxyHealth chambers are FDA 510(k) cleared Class II medical devices. Every Fortius hard shell is built to ASME PVHO-1, individually stamped and serialized, third-party inspected, and documented on its GR-1 form.
Chapter 4
Delivered, set up, and explained.
Our team coordinates delivery and gives you the training to operate your chamber with confidence. Fortius chambers are installed, assembled and calibrated by OxyHealth certified technicians.
Chapter 5
We stay with you for the life of your chamber.
Your relationship with OxyHealth does not end at installation. You keep one dedicated representative, U.S. based parts, service and technical support, and a 5 year manufacturer warranty on every chamber.
19,000+ chambers delivered since 1997
Every one of them started the same way yours will: with a conversation.
The OxyHealth credential file
The gold standard, in writing.
Anyone can print the words gold standard. A standard is something you can check. Here is what stands behind every OxyHealth chamber, and the document to ask for each time.
- OxyHealth, LLCCredential file
FDA 510(k) cleared
- Applies to
- OxyHealth hyperbaric chambers, as Class II medical devices (product code CBF, 21 CFR 868.5470)
- What it means
- The FDA reviewed the device and found it substantially equivalent to a legally marketed device. Registration alone is a listing, not a review.
- Ask any manufacturer for
- The 510(k) clearance letter for the exact model, then look it up on the FDA database yourself.
- OxyHealth, LLCCredential file
ASME PVHO-1
- Applies to
- Fortius 420 and Fortius 420 EXP hard shell chambers
- What it means
- Built to the ASME standard for pressure vessels for human occupancy. Each chamber is individually stamped and serialized, and third-party inspected.
- Ask any manufacturer for
- The GR-1 form for the chamber’s serial number.
- OxyHealth, LLCCredential file
ISO 13485
- Applies to
- How every OxyHealth chamber is made
- What it means
- Manufactured under an ISO 13485 certified quality management system, the international standard for medical device quality.
- Ask any manufacturer for
- The manufacturer’s ISO 13485 certificate.
- OxyHealth, LLCCredential file
UL certified components
- Applies to
- Electrical components, where applicable
- What it means
- The electrical parts inside the system carry UL certification.
- Ask any manufacturer for
- Confirmation that the electrical components are UL certified.
- OxyHealth, LLCCredential file
Made in the USA, since 1997
- Applies to
- Design, manufacturing and support
- What it means
- More than 19,000 chambers delivered, designed, built and supported in the USA, with long-term parts, service and technical support.
- Ask any manufacturer for
- Who services the chamber, where the parts come from, and who you call in year ten.
- OxyHealth, LLCCredential file
5 year warranty
- Applies to
- Every OxyHealth chamber
- What it means
- Every OxyHealth chamber, from the Respiro 270 to the Fortius 420 EXP, is backed by a 5 year manufacturer warranty.
- Ask any manufacturer for
- The written warranty terms for the model you are considering.
Ask every manufacturer these questions.
The International Hyperbaric Association recommends asking them before you buy any chamber. Here are our answers.
See all the safety questions- Can you provide the FDA 510(k) letter for this chamber?
- Yes. Ask us for the letter for the model you are considering.
- Is the chamber ASME PVHO-1 stamped and serialized, with a GR-1 form?
- Yes, every Fortius hard shell chamber.
- Is the manufacturer ISO 13485 certified?
- Yes.
- Are the electrical components UL certified?
- Yes, where applicable.
- What ongoing support does the manufacturer provide?
- One dedicated representative, plus U.S. based parts, service and technical support.
- How long is the warranty and what does it cover?
- 5 years on every OxyHealth chamber. Ask us for the written terms for your model.
Before you buy anywhere
FDA cleared is not FDA registered
The two terms sound alike and mean very different things. Knowing the difference protects you from any chamber, from any seller.
FDA 510(k) cleared
The OxyHealth standard
- The specific device was submitted to and reviewed by the FDA
- Found substantially equivalent to a legally marketed device
- Hyperbaric chambers are Class II devices, product code CBF
- The manufacturer can show you a 510(k) clearance letter
FDA registered
Not the same thing
- A company has listed its establishment and devices with the FDA
- Registration is not a review of the device
- It does not mean the device is cleared
- Ask for the 510(k) letter, not the registration number
Always ask for the FDA 510(k) clearance letter, and for a hard shell chamber, the ASME PVHO-1 GR-1 form. View OxyHealth FDA documentation.
You would be in good company
Chosen by people who cannot afford to guess
OxyHealth chambers have been selected by military organizations, elite athletes, healthcare professionals and clinics around the world, and have been used in published peer-reviewed research.
Common questions
Frequently Asked Questions
Answers about OxyHealth chambers, certifications, support and financing.
OxyHealth has designed, built and supported hyperbaric chambers in the USA since 1997, with more than 19,000 chambers delivered. Its chambers are FDA 510(k) cleared Class II medical devices, its Fortius hard shell chambers are built to ASME PVHO-1 and individually stamped and serialized, and every chamber is manufactured under an ISO 13485 certified quality management system. Each customer keeps one dedicated representative from the first call through years of ownership.
Yes. OxyHealth hyperbaric chambers are FDA 510(k) cleared as Class II medical devices. 510(k) clearance means the FDA reviewed the device and found it substantially equivalent to a legally marketed device. Ask OxyHealth for the clearance documentation for the model you are considering.
The Fortius 420 and Fortius 420 EXP hard shell chambers. Each one is built to ASME PVHO-1, the pressure vessel standard for human occupancy, individually stamped and serialized, third-party inspected, and documented on its GR-1 form.
FDA 510(k) clearance means the FDA has reviewed a specific device and found it substantially equivalent to a legally marketed device. FDA registration means a company has listed its establishment and devices with the FDA, which is not a review of the device. Always ask a manufacturer for the 510(k) clearance letter.
OxyHealth chambers are built with medical-grade materials and a compressor engineered specifically for hyperbaric use, manufactured in the USA under an ISO 13485 quality system, and backed by U.S. based parts, service and a dedicated representative. Contact OxyHealth for pricing. Flexible financing is available.
One dedicated representative from your first conversation through years of ownership, delivery coordination and training, and U.S. based parts, service and technical support. Fortius chambers are installed, assembled and calibrated by OxyHealth certified technicians, and every OxyHealth chamber is backed by a 5 year manufacturer warranty.
Yes. Financing is available through Brickhouse Capital with up to 100% financing and terms from 24 to 60 months, for physicians, clinics and individual buyers.
Your chapter starts with a conversation.
Talk with a hyperbaric specialist about your home or your practice. We will be there for every chapter after that.