When evaluating hydrogen-oxygen generators, it is essential to consider three key criteria: gas concentration, flow rate, and regulatory certification. Concentration and flow rate influences therapeutic efficacy, whereas certification ensures clinical safety and long-term reliability.
Clinical research has demonstrated that a gas mixture of 66.6% hydrogen (H₂) and 33.3% oxygen (O₂) yields the most effective therapeutic results. Lower hydrogen concentrations lead to limited or negligible effects. Excessively high hydrogen concentrations, in the absence of sufficient oxygen, induces hypoxic responses. Hypoxia may accelerate tumor growth and metastasis, making a medically balanced gas ratio critical for safety and efficacy.
Higher gas flow rates improve hydrogen delivery and absorption. While most machines range from 300–1200 mL/min, a flow rate of 3000 mL/min is considered optimal for home care and adjunctive therapy.
Hydrogen-oxygen generators are classified as Class III medical devices, indicating they must meet the highest standards for medical safety and effectiveness. Devices without relevant certifications may provide short-term symptomatic relief but pose serious health risks, including hepatic and renal damage and increased risk of leukemia. Class III certification ensures the machine has undergone rigorous clinical validation and is safe for long-term, side-effect-free use in hydrogen-oxygen therapy.
Among all hydrogen-oxygen generators available, Asclepius Meditec’s hydrogen-oxygen neubliser is currently the only one officially approved for medical use. It has passed rigorous evaluation by the National Medical Products Administration (NMPA) and is classified as a Class III medical device.
Most hydrogen or hydrogen-oxygen generators on the market rely on industrial-grade hydrogen production technologies, which are not intended for human inhalation and lack medical certification.
According to national regulations, any device generating hydrog en or hydrogen-oxygen gas for medical purposes must now be regulated as a Class III medical device, subject to approval. Currently, many commercial hydrogen generators fall outside of this regulation and present unverified safety risks:
These technologies do not meet medical safety standards and may carry risks including liver and kidney toxicity or even hematological side effects. Asclepius Meditec has innovated beyond traditional water electrolysis methods, using technology fully compliant with Class III medical device standards that passed comprehensive biocompatibility, toxicology, and electromagnetic safety (EMC) evaluations. Each internal component is NMPA-approved, and the device is designed to meet “National Innovation” status, ensuring that it is medically safe, effective, and suitable for long-term use.
Yes. Asclepius Meditec is the pioneer of hydrogen-oxygen therapy and currently sets the industry’s highest regulatory and clinical standards. As of now, Asclepius Meditec is the only company in the hydrogen-oxygen device sector that has been officially approved by the National Medical Products Administration (NMPA) of China as a Class III medical device for domestic-use clinical applications. This classification represents the strictest level of safety and efficacy requirements for medical devices.
Hydrogen-oxygen inhalation devices are classified as Class III medical devices globally, including the United States (FDA), European Union (EMA), and Japan (PMDA), due to their high-risk nature and potential for biological interaction. The classification is based on the following factors:
Therefore, any hydrogen or hydrogen-oxygen generators intended for human use must undergo rigorous approval by national regulatory authorities, adhering to comprehensive safety, efficacy, and toxicology testing protocols. Devices that do not meet Class III standards may pose serious long-term health risks, such as chemical exposure, carcinogenicity, and organ toxicity, with effects that may only become clinically apparent after 10 to 20 years of use.
Oxygen concentrators are primarily designed to improve blood oxygen saturation. In contrast, hydrogen-oxygen nebulizers not only support oxygen saturation but also offer additional therapeutic benefits, including antioxidant, anti-inflammatory effects, and enhanced oxygen transport due to hydrogen's carrier properties.
If your home oxygen concentrator provides a flow rate of 2 L/min or higher, it is recommended to use it in combination with a hydrogen-oxygen nebulizer. However, if your oxygen concentrator provides only 1–2 L/min, the hydrogen-oxygen device alone is sufficient (3 L/min hydrogen-oxygen nebuliser typically delivers 2 L/min of hydrogen gas and 1 L/min of oxygen. Due to hydrogen’s ability to facilitate oxygen transport, this configuration offers an equivalent therapeutic effect to that of a 1–2 L/min low-flow home oxygen concentrator). Hence, consider the hydrogen-oxygen nebulizer as an advanced alternative to traditional oxygen therapy.
For first-time users, monitoring pulse oximetry is advised to assess individual response.
