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Only 3 portable chamber brands hold FDA 510(k) clearance in the US: OxyHealth, Summit to Sea, and Newtowne Hyperbarics. For clinical hard-shell systems, Perry Baromedical and Sechrist Industries are the two FDA-registered manufacturers that dominate hospital installations. The manufacturer you choose determines your pressure ceiling, your regulatory standing, and whether you can get parts and service 5 years from now.
Key Takeaways
- Only three portable chamber brands hold FDA 510(k) clearance in the US: OxyHealth, Summit to Sea, and Newtowne Hyperbarics, per the FDA 510(k) database.
- Perry Baromedical and Sechrist Industries are the two FDA-registered clinical manufacturers that dominate US hospital and wound care installations.
- OxyHealth reports over 18,000 chambers distributed in 28 years and offers the category’s longest warranty at 5 years, capped at 1.3 ATA.
- Perry Baromedical builds multiplace chambers up to 6.0 ATA with ISO 13485:2016 certification; Sechrist has manufactured clinical chambers since 1973.
- FDA approved, FDA cleared, and FDA registered are three distinct designations, and no hyperbaric chamber holds FDA approved status.
What is the difference between FDA approved, cleared, and registered?
The three terms describe completely different things, and sellers misuse them constantly. Understanding them protects you from misleading listings before you review any manufacturer. The FDA 510(k) database is the authority on which specific products are cleared.
FDA and certification status, defined
- FDA Approved: Reserved for Class III devices and drugs after a full premarket approval review. No hyperbaric chamber holds this status.
- FDA Cleared (510k): The device was reviewed and cleared for a specific indication (altitude sickness). This is the correct term for portable chambers: OxyHealth, Summit to Sea, Newtowne.
- FDA Registered: The manufacturing facility filed registration paperwork. It does not mean any product was reviewed. Perry, Sechrist, and some overseas factories are registered.
- CE Mark: Meets European health and safety standards. Separate from the FDA; does not satisfy US requirements.
- ASME PVHO-1: Engineering standard for Pressure Vessels for Human Occupancy. Voluntary, but the gold standard for clinical hard-shell chambers.
| Term | What It Means | Who It Applies To |
|---|---|---|
| FDA Approved | Reserved for Class III devices and drugs. No hyperbaric chamber holds this status. | No chamber manufacturer |
| FDA Cleared (510k) | Device reviewed and cleared for a specific indication via the 510(k) pathway. Correct term for portable chambers. | OxyHealth, Summit to Sea, Newtowne |
| FDA Registered | Manufacturing facility is registered with the FDA. Does NOT mean products are cleared. | Perry, Sechrist, and some Chinese factories |
| CE Mark | Meets European health and safety standards. Separate from the FDA; does not satisfy US requirements. | International manufacturers (Zeugma, OxyRevo, Dr Hugo) |
| ASME PVHO-1 | Engineering standard for pressure vessels for human occupancy. Voluntary but gold standard. | Perry, Sechrist, optionally Zeugma |
| ISO 13485 | Quality management system standard for medical device manufacturers. | Perry, some international manufacturers |
Which manufacturers hold FDA 510(k) clearance for portable chambers?
OxyHealth (USA)
OxyHealth is the largest portable hyperbaric chamber manufacturer by volume, reporting over 18,000 chambers distributed in 28 years. It holds FDA 510(k) clearance for altitude sickness, is used by US Special Forces and the International Olympic Committee, and offers the longest warranty in the category at 5 years. The Vitaeris 320 and Fortius series are the most widely deployed home chambers in the US. Max pressure: 1.3 ATA.
Summit to Sea (USA)
Summit to Sea has manufactured portable chambers for more than 30 years and holds FDA 510(k) clearance. Its Grand Dive model is the most popular home chamber on Amazon and through authorized dealers, with a 33-inch internal diameter and reinforced urethane construction. Standard warranty is 2 years. Max pressure: 1.3 ATA.
Newtowne Hyperbarics (USA)
Newtowne holds FDA 510(k) clearance K051759 for its portable chambers, cleared for acute mountain sickness at 1.3 ATA. It is positioned as the budget-accessible option among FDA-cleared brands, with prices starting around $4,000 to $5,500. Standard warranty is 2 years. Max pressure: 1.3 ATA.
Which manufacturers build clinical (FDA-registered) chambers?
Perry Baromedical (USA)
Perry Baromedical (Riviera Beach, Florida) is the world leader in clinical hyperbaric systems. It produces the BARA-MED monoplace series and multiplace chambers up to 6.0 ATA, holding FDA registration and ISO 13485:2016 certification. Perry systems are installed in hospitals and wound care centers globally, and its used/refurbished program is the most affordable path to a clinical-grade chamber. Perry states that its chambers save approximately $8,000 per year in oxygen costs versus competitors, a manufacturer claim.
Sechrist Industries (USA)
Sechrist Industries (Anaheim, California) has manufactured monoplace and multiplace clinical chambers since 1973. It holds FDA registration and ASME PVHO-1 certification and runs a Certified Pre-Owned program with a 90-day limited OEM warranty on refurbished units. Max pressure: 3.0 ATA. Parts availability for older Sechrist chambers is excellent; hospitals regularly run units installed 20 or more years ago.
ETC / Baramed (USA)
ETC (Environmental Tectonics Corporation) produces monoplace clinical chambers. FDA registered. Max pressure: 3.0 ATA. It primarily serves the hospital and military market.
Are CE-certified chambers safe to buy?
CE-certified chambers are legitimate for home wellness use but cannot be marketed as medical devices in the US. These international manufacturers meet European standards without FDA clearance.
HPO Tech / Zeugma (Turkey)
HPO Tech produces the Zeugma line, the only product spanning the full 1.5 to 3.0 ATA range from a single manufacturer. Built from aerospace-grade aluminum, available in 170+ RAL colors, with optional ASME PVHO-1 and Medical CE certification (EU MDR 2017/745). CE certified; not FDA cleared.
Dr Hugo / LANNX Biomedical (China)
LANNX Biomedical reports 18 years of medical device manufacturing and 10+ years in HBOT. CE and ISO 13485 certified. Its chambers are installed in 1,000+ hospitals across 150+ countries, and it is one of the few brands producing 2.0 ATA soft-shell chambers. Not FDA cleared.
OxyRevo (International)
OxyRevo offers the Apex soft-shell series (1.5 ATA) and Quest/Space hard-shell series (1.5 to 2.0 ATA). CE certified. It covers the widest pressure range among non-FDA brands in portable format. Not FDA cleared.
Macy-Pan (China)
CE certified. Budget-to-mid-range home and clinical models at 1.3 to 2.0 ATA, available through multiple channels including Amazon. Not FDA cleared.
How do the manufacturers compare side by side?
| Manufacturer | Country | FDA Status | CE | ISO 13485 | ASME PVHO-1 | Max ATA | Home Models |
|---|---|---|---|---|---|---|---|
| OxyHealth | USA | 510(k) Cleared | No | No | No | 1.3 | Yes |
| Summit to Sea | USA | 510(k) Cleared | No | No | No | 1.3 | Yes |
| Newtowne | USA | 510(k) Cleared | No | No | No | 1.3 | Yes |
| Perry Baromedical | USA | Registered | No | Yes | Yes | 6.0 | No |
| Sechrist Industries | USA | Registered | No | No | Yes | 3.0 | No |
| HPO Tech (Zeugma) | Turkey | No | Yes (opt. Medical) | No | Optional | 3.0 | Wellness |
| OxyRevo | International | No | Yes | No | No | 2.0 | Yes |
| Dr Hugo / LANNX | China | No | Yes | Yes | No | 2.0 | Yes |
| Macy-Pan | China | No | Yes | No | No | 2.0 | Yes |
Which hyperbaric chamber manufacturer is best for my use case?
The right manufacturer depends on whether you want an FDA-cleared home unit, a higher-pressure wellness chamber, or a clinical system. This table maps common goals to the best-fit brands. For the full pricing picture, see the cost to buy a hyperbaric chamber guide, and for the pressure trade-off see hard shell vs soft shell.
| Use Case | Best Manufacturer(s) | Why |
|---|---|---|
| Budget home use (FDA cleared) | Newtowne, Summit to Sea | Lowest FDA-cleared prices ($4,000 to $5,500) |
| Premium home use (FDA cleared) | OxyHealth | Best warranty (5 yr), largest installed base |
| Home use above 1.3 ATA | OxyRevo, Dr Hugo | 1.5 to 2.0 ATA options (CE only, not FDA cleared) |
| Clinical monoplace | Perry Baromedical, Sechrist | Gold standard, full FDA compliance, ASME PVHO-1 |
| Clinical on budget | Zeugma (Medical CE), used Perry/Sechrist CPO | Clinical pressures at lower cost than new US clinical |
| Clinic wellness offering | Zeugma, Eclipse Elite | Premium aesthetics, intermediate pressures |
Perry Baromedical remains the world leader in clinical hyperbaric chambers, with ISO 13485 certification and hospital installations globally. Its used and refurbished program is the most affordable route to a clinical-grade chamber.
Frequently Asked Questions
Which hyperbaric chamber manufacturer has the best warranty?
For portable home chambers: OxyHealth offers the longest standard warranty at 5 years. For clinical chambers: Perry Baromedical and Sechrist offer the most comprehensive ongoing support, including OEM parts availability for chambers installed decades ago.
Is a CE-certified chamber good enough for home use?
CE certification meets European standards and is meaningful for home wellness use. However, CE does not satisfy FDA requirements and the chamber cannot be legally marketed as a medical device in the US. For home wellness use, CE-certified chambers from established manufacturers like Dr Hugo or OxyRevo are an option, but FDA-cleared chambers from OxyHealth or Summit to Sea provide a higher regulatory baseline.
What is ASME PVHO-1 and why does it matter?
ASME PVHO-1 (Pressure Vessels for Human Occupancy) is the engineering standard for hyperbaric chamber construction. It is voluntary, not legally required, but it is the gold standard for clinical chambers. A clinical hard-shell chamber at 2.0 ATA or higher that does not meet ASME PVHO-1 lacks the engineering validation that the vessel can safely contain the forces involved. Perry Baromedical and Sechrist both build to this standard.
Sources
- US FDA 510(k) Premarket Notification Database; Newtowne clearance K051759. accessdata.fda.gov
- OxyHealth. Company overview (manufacturer figures for units distributed and warranty). oxyhealth.com
- Perry Baromedical. About Us and product literature. perrybaromedical.com
- Sechrist Industries. Hyperbaric products. sechristusa.com
- HPO Tech (Zeugma). Product specifications. hpotech.com
- ASME PVHO-1: Safety Standard for Pressure Vessels for Human Occupancy. asme.org
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The content on BaricBoost.com is for informational purposes only and is not intended as a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.
Author
Seph Fontane Pennock is the founder of BaricBoost.com and Regenerated.com, a clinic directory for regenerative medicine serving 10,000+ providers across the United States. He previously built and sold PositivePsychology.com, which grew to 19 million users and became the largest evidence-based positive psychology resource on the web. Seph brings direct experience as an HBOT patient, having completed protocols at clinics across three continents while navigating mold illness, systemic inflammation, and autoimmune conditions. His treatment journey includes hyperbaric oxygen therapy, peptide protocols, NAD+ therapy, and consultations with specialists from Dubai to Cape Town to Mexico. This combination of entrepreneurial track record and lived patient experience shapes everything published on BaricBoost.com. Every article is grounded in peer-reviewed research, informed by real clinical encounters, and written for patients making high-stakes treatment decisions. Seph's focus is on bringing transparency, scientific rigor, and practical guidance to the hyperbaric oxygen therapy space.
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