Hyperbaric chamber manufacturers around the world (2026)
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Certification sounds like a single box to tick. In hyperbaric medicine, it involves several distinct requirements. Medical-device regulation, pressure-vessel engineering standards, and quality-system certification serve different purposes and should not be treated as interchangeable credentials.
A hyperbaric chamber is a pressure vessel built for human occupancy, so its design must account for pressure, patient safety, and the conditions inside the chamber. Requirements also vary between markets, and authorization in one country does not automatically establish eligibility in another.
The manufacturers below offer examples of companies working in this field, and their listed certifications.
United States (FDA)
Sechrist Industries (USA)
Sechrist has manufactured monoplace chambers in Anaheim, California, since 1973. Its focus is on single-patient chambers for clinical use. Buyers should confirm the documentation and intended use of the specific model they are considering.
Perry Baromedical (USA)
Perry manufactures monoplace and multiplace hyperbaric chambers, offering options for treating individual patients or several patients within the same chamber. Its product range serves clinical hyperbaric treatment settings.
Europe (EU MDR)
Comex (France)
Comex has been building human-occupancy pressure vessels since 1961, from saturation diving systems and submarines to hyperbaric test centres. Its work includes medical hyperbaric systems alongside equipment for diving and pressure research.
IHC Hytech / Hytech-Pommec (Netherlands)
IHC Hytech / Hytech-Pommec works across diving, tunnelling, naval, and medical applications. Its medical hyperbaric systems form part of a broader range of pressure and life-support equipment.
Submarine Manufacturing & Products (UK)
SMP has been a subsea specialist since 1985, spanning commercial diving, military systems and submarine rescue alongside medical hyperbaric chambers. Its medical range includes a twin-lock chamber design.
HPO.TECH (Türkiye)
HPO.TECH manufactures hyperbaric and hypobaric chambers for sports recovery clinics, ,hospitals, high-end hotels and wellness clinics as well as for private use. As with the other manufacturers listed, buyers should assess the proposed chamber’s specifications, supporting documentation, and suitability for their intended market.
Australia (TGA)
Fink Engineering
Fink develops rectangular medical hyperbaric chambers. Its chamber design provides another configuration for buyers to consider alongside cylindrical monoplace and multiplace systems.
What does it mean to be certified in 2026?
The word “certified” carries less information than it appears to, because the type and scope of the credential matter. ASME PVHO-1 addresses pressure vessels for human occupancy, while ISO 13485 sets requirements for medical-device quality management systems. These serve different purposes from authorization to market a medical device.
For buyers, the relevant question is whether the specific chamber meets the requirements for its intended use and location. Comparing manufacturers therefore requires checking the scope of their documentation, rather than simply counting credentials.
Frequently asked questions
What certifications should a hyperbaric chamber manufacturer hold?
It depends on where the chamber will be used and its intended purpose. Buyers should check the applicable medical-device requirements, pressure-vessel and fire-safety requirements, and any relevant quality-system documentation. These categories should be assessed separately.
What is the difference between FDA clearance and EU MDR?
According to the FDA, hyperbaric oxygen therapy devices are Class II medical devices cleared through the US 510(k) process. EU MDR is the European Union’s Medical Device Regulation. Medical devices undergo the applicable conformity assessment before bearing a CE mark, as explained by the European Medicines Agency. They are separate regulatory frameworks.
How should buyers assess a manufacturer’s credentials?
Request current documentation for the exact chamber model, including its scope and the issuing authority or organization. Check whether each document concerns the device, its pressure-vessel design or the manufacturer’s quality system.
Is a CE mark the same as medical certification?
A CE mark indicates conformity with applicable EU legislation. Buyers should check the accompanying declaration of conformity to establish which legislation it covers, rather than assuming that any CE mark establishes medical-device status.
Are wellness or soft-shell chambers certified the same way as medical chambers?
Buyers should check the specific product’s intended use and regulatory status. Labels such as “wellness” or “soft-shell” alone do not establish whether a chamber is authorized for medical treatment.
Hyperbaric chamber manufacturers around the world (2026)
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