AHA Hyperbarics - Innovations

Invest in one of the safest and credible HBOT solutions

AHA Hyperbarics devices are premium HBOT solutions, backed by a comprehensive range of certifications.

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.

 

AHA Hyperbaric Solutions meet the strictest EU quality standards:

AHA Hyperbarics_Certificate_EN-ISO 134852016

We guarantee exceptional production quality with ISO EN 13485:2016

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.

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We ensure the highest safety and efficiency for patients with EC Certificate (CE 0123).

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:

  • a high level of protection for human health and safety when using AHA Hyperbaric systems and
  • that AHA Hyperbaric systems achieve the results for which our medical devices are intended.

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.

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With the confirmation letter, issued by TÜV SÜD Product Service GmbH, designated under MDR and identified by the number 0123 on NANDO, confirms that AHA Hyperbarics (SRN Number: AT-MF-000023416) meets all requirements and is transitioning to MDR. For confirmation letter validity see: Certificate Explorer 104291 0005 Rev. 00

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The products included in the AHA Hyperbaric Medical System are certified medical devices.

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.

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Verified by medical research: AHA Medical System’s approved medical indications

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:

  • Autism (2-16 years of age)
  • Cerebrovascular insult (CVI) – stroke
  • Crush injuries
  • Diabetic foot ulcer
  • Intestinal cystis / Paintful bladder syndrome
  • Post-concussion syndrome (PCS) after mild traumatic brain injury
  • Scleral ischaemia or melt

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AHA Hyperbarics - PVHO certificate EN14931:2006

Only AHA inflatable chambers meet the rigorous standards of hard hyperbaric chambers: PVHO EN 14931:2006

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.

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AHA Hyperbarics - FDA LOGO

AHA Hyperbarics Systems sold in U.S. are FDA approved

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:

  • 510(k) no.: K101262
  • Device listing no.: D304172
  • Owner operator no: 10055865

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List of applied standards

IEC 60601-1-2:2014
Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests

EN 60601-1:2006 + A1:2013 + A12:2014
Medical electrical equipment. General requirements for basic safety and essential performance

EN ISO 80601-2-69:2014
Medical electrical equipment, Part 2: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment

EN 60601-1-6:2010 + A1:2015
Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Usability

IEC 62366:2007 + A1:2014
Standard | Amendment 1 – Medical devices – Application of usability engineering to medical devices.

EN ISO 14971:2012
Medical devices. Application of risk management to medical devices

EN 980:2014
European standard for symbols used by medical device manufacturers.

EN ISO 10993-5:2009-10
Biological evaluation of medical devices. Tests for in vitro cytotoxicity.

EN ISO 10993-10:2013
Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization

AHA Hyperbaric Medical System - CE01234

One of the kind in the world:
AHA Hyperbaric Medical System

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.

 

AHA SYSTEMS CHECK OUR CERTIFICATES

We provide all our clients with customized HBOT solutions

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.

Start your AHA Hyperbarics journey today:

Solutions for medical use
AHA Hyperbaric Medical System - CE01234

Medical 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.

Solutions for Wellness use
AHA Wellness or Home system - Fit

Wellness System

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.