Are you interested in acquiring your own AHA Hyperbaric Chamber?
We at AHA Hyperbarics wholeheartedly share what we know – not just with each other, but with anyone who wants to explore the benefits of Hyperbaric Medicine.
With a strong emphasis on safety and effectiveness, AHA Hyperbarics Systems have undergone rigorous testing and meet the highest industry standards for medical devices. We are one of the few HBOT innovators and educators in the world that can guarantee the highest quality of HBOT technologies and trainings. Our certifications are public and accessible for you to review, either on our website below or on the websites of the notified bodies that issue them.
With our certified excellence we are able to provide you with an extremely safe and reliably effective hyperbaric experience, setting new benchmarks for quality in the market.
ISO EN 13485:2016, an internationally recognized standard, provides a valuable quality management system for organizations involved in the design, production, installation, and servicing of medical devices. This standard ensures that companies consistently meet customer and regulatory requirements, managing quality throughout the device’s life cycle.
By applying sound risk management processes, ISO EN 13485:2016 minimizes risks associated with medical devices. In the highly regulated medical devices industry, complying with this standard is essential to produce safe and effective devices fit for their intended purpose.
This certificate demonstrates that AHA Hyperbarics complies with the strict Medical Device Directive 93/42/EEC, that regulate the area of medical devices. This certificate ensures a high level of protection for patients. With EC Certificate (CE 0123) we guarantee:
Our EC Certificate was issued by TÜV SÜD, a well-known and recognized body approved by the European Conformity organization. We encourage you to learn more about this certification.
We confirm that the AHA Hyperbaric Medical System (or AHA Flex hyperbaric system) complies with the relevant EC Council Directives and Standards for medical devices (see the EC Certificate above).
Furthermore, we declare that all AHA Hyperbarics’ products included in the AHA Hyperbaric Medical System are classified as medical devices.
We confirm that extensive research of effect of medical HBOT was conducted during the medical certification process (refer to EC Certificate above). These studies have shown notable improvements in patient conditions when using hyperbaric oxygen therapy for the following medical conditions:
We are the only manufacturer of inflatable hyperbaric chambers in the world that conforms to the standards for hard, multi-place hyperbaric chambers.
Our innovative AHA Hyperbaric systems meet the stringent safety standards of EN 14931:2006 for pressure vessels designed for human occupancy. This certification ensures that our inflatable medical hyperbaric systems, conform to the same rigorous standards as traditional hard, multi-place hyperbaric chambers.
It validates the performance, safety, and testing requirements of our chambers, making it a prerequisite for our EC Certificate for medical devices.
FDA approval confirms that AHA Flex 20s chamber is safe and effective for the intended use, and that AHA Hyperbarics company can manufacture the product to federal quality standards. If the FDA grants an approval, it means the agency has determined that the benefits of the product outweigh the risks for the intended use.
AHA Flex 20s chamber (4 psi) is approved by FDA and sold by our U.S. subsidiary:
Our AHA Hyperbaric Medical System is certified according to the European Council Directive concerning medical devices (MDD) 93/42/EEC and produced on the basis of the quality management system for the production of medical products as determined by EN ISO 13485:2016.
Due to their functionality and safe use, AHA Hyperbarics Medical System can be used for medical, as well as non-medical or relaxation purposes.
We design custom AHA Hyperbaric Solutions for each of our clients, addressing their unique requirements for either medical, wellness, or personal purposes. We prioritize safety and user-friendliness, offering a durable device with minimal maintenance requirements when used correctly.
All AHA Hyperbaric Solutions consist of AHA Hyperbarics System, the technological infrastructure needed for HBOT, and AHA Knowledge transfer services to provide our clients with expertise to deliver HBOT treatments properly with their system.
Our certified devices meet all necessary standards for safe and effective use in medical settings, distinguishing it as a leading choice among hyperbaric chambers worldwide.
This unique system has 26 patented solutions that contribute to unparalleled experience of hyperbaric oxygen therapy: both for the chamber operator as well as the end (treatment) user.