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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.
Understanding the Three Types of Certification
Before reviewing any manufacturer, understand the certification landscape. The terminology is frequently misused by sellers, and the differences matter.[1]
| 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 510(k) pathway. Correct term for portable chambers. | OxyHealth, Summit to Sea, Newtowne |
| FDA Registered | Manufacturing facility is registered with FDA. Does NOT mean products are cleared. | Perry, Sechrist, and some Chinese factories |
| CE Mark | Meets European health and safety standards. Separate from 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 |
FDA-Cleared Portable Chamber Manufacturers
OxyHealth (USA)
OxyHealth is the largest portable hyperbaric chamber manufacturer by volume, with over 18,000 chambers distributed in 28 years. They hold FDA 510(k) clearance for altitude sickness, are used by the US Special Forces and the International Olympic Committee, and offer the longest warranty in the category (5 years). Their Vitaeris 320 and Fortius series are the most widely deployed home chambers in the US market. Max pressure: 1.3 ATA.[1]
Summit to Sea (USA)
Summit to Sea has been manufacturing portable hyperbaric chambers for 30+ years and holds FDA 510(k) clearance. Their 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.[1]
Newtowne Hyperbarics (USA)
Newtowne holds FDA 510(k) clearance (K051759) for their portable chambers. They are positioned as the budget-accessible option among FDA-cleared brands, with prices starting around $4,000–$5,500. Standard warranty is 2 years. Max pressure: 1.3 ATA.[1]
Clinical Chamber Manufacturers (FDA Registered)
Perry Baromedical (USA)
Perry Baromedical (Riviera Beach, Florida) is the world leader in clinical hyperbaric systems. They produce 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. Their used/refurbished program offers the best value path to a clinical-grade chamber. Manufacturer claim: their chambers save approximately $8,000 per year in oxygen costs versus competitors.[1]
Sechrist Industries (USA)
Sechrist Industries (Anaheim, California) has been manufacturing monoplace and multiplace clinical chambers since 1973. They hold FDA registration and ASME PVHO-1 certification and offer a Certified Pre-Owned (CPO) program with 90-day limited OEM warranty on refurbished units. Max pressure: 3.0 ATA. Parts availability for older Sechrist chambers is excellent; hospitals regularly operate units installed 20+ years ago.[1]
ETC / Baramed (USA)
ETC (Environmental Tectonics Corporation) produces monoplace clinical chambers. FDA registered. Max pressure: 3.0 ATA. Primarily serves the hospital and military market.
International Manufacturers: CE Certified, Not FDA Cleared
HPO Tech / Zeugma (Turkey)
HPO Tech produces the Zeugma chamber line, the only product spanning the full pressure range from 1.5 to 3.0 ATA from a single manufacturer. Constructed from aerospace-grade aluminum, available in 170+ RAL color codes, with optional ASME PVHO-1 and Medical CE certification (EU MDR 2017/745). The Zeugma bridges the gap between consumer wellness and clinical medicine. CE certified; not FDA cleared.[1]
Dr Hugo / LANNX Biomedical (China)
LANNX Biomedical has 18 years of medical device manufacturing experience and 10+ years in HBOT. CE and ISO 13485 certified. Their chambers are installed in 1,000+ hospitals across 150+ countries. Offers integrated ecosystems including chambers, concentrators, monitors, and telehealth. One of the few brands producing 2.0 ATA soft-shell chambers. Not FDA cleared.[1]
OxyRevo (International)
OxyRevo offers the Apex soft-shell series (1.5 ATA) and Quest/Space hard-shell series (1.5–2.0 ATA). CE certified. Covers the widest pressure range among non-FDA brands in portable format. Not FDA cleared.[1]
Macy-Pan (China)
CE certified. Budget-to-mid range home and clinical models at 1.3–2.0 ATA. Available through multiple distribution channels including Amazon. Not FDA cleared.[1]
Complete Manufacturer Comparison Table
| 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 |
Matching Manufacturer to Use Case
| Use Case | Best Manufacturer(s) | Why |
|---|---|---|
| Budget home use (FDA cleared) | Newtowne, Summit to Sea | Lowest FDA-cleared prices ($4,000–$5,500) |
| Premium home use (FDA cleared) | OxyHealth | Best warranty (5 yr), largest installed base |
| Home use above 1.3 ATA | OxyRevo, Dr Hugo | 1.5–2.0 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 |
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 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.
References
- FDA 510(k) Database; Newtowne clearance K051759. accessdata.fda.gov
- OxyHealth. Company Overview. oxyhealth.com
- Perry Baromedical. About Us. perrybaromedical.com/about-us/
- Sechrist Industries. Products. sechristusa.com
- HPO Tech (Zeugma). hpotech.com
- ASME PVHO-1 Standard. asme.org
Medical Disclaimer
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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