Compliance
All Elanra medical devices have been designed to comply with the Australian TGA and European CE Medical standards. These advanced Cold Air Plasma medical devices which produce therapeutic air ions are unique, and are the only ones of their kind in the world. Our science and technology is protected by patents, trademarks and trade secrets, they are verified through the many years of experience with over 1 Million patients benefiting from their effects and ensuring efficacy of their clinical use.
The medical standards required are much higher than the standards required for a normal electrical device. When it comes to your health, ONLY insist on ‘Registered Medical Devices’, that are permitted to make registered claims which could benefit your health. In 2021, some countries are altering their medical standards, we are in the process of complying with these new standards, and will update our web site as our engineering and legal departments permit. Bionic Products is the manufacturer and Bionic Air is the distributor. Both continue to comply with ISO13485 standards for medical quality management systems.
We take pride in the quality of our medical devices to give you positive health results. That means it is important to take these devices seriously, and importantly read your instruction manual before use. Our medical devices are designed for your body and blood, usually as you sleep. They also have the ability to clear pathogens in the room air and on surfaces to prevent cross infection, but that is a bonus to its core purpose which is your body and blood.
You can relax knowing that our products help you to breathe clean and healthy air while placing an emphasis on your safety.
Elanra MKII from Bionic Air
The Elanra MkII is a Stationary device operating on wall power not a battery. As the most technically advanced personal Cold Air Plasma medical device in the world, incorporating the finest components including a formulated casing that does not outgas or produce toxins. This award-winning product is suitable for all ages, all conditions and those who are highly sensitive or allergic to chemicals and synthetics.
It is our flagship device and used by a large range of patients for over 40 years, with 144 medical settings. Designed to complement your lifestyle, the Elanra MKII performs perfectly with windows and doors open or closed and even with the air conditioning on. Almost silent when operating and certified for use in doctors rooms, child care facilities, aged care homes and hospitals, the Elanra MKII complies with required safety and electrical standards for medical devices and does not produce detrimental gases to your health.
Elanra MKIII from Bionic Air
Designed to complement your lifestyle, the Elanra MKIII is Portable performs perfectly with windows and doors open or closed and even with the air conditioning on. Completely silent when operating, and certified for use in cars, trucks, airplanes, hospitals or at home. The MKIII complies with medical safety and electrical standards and does not produce detrimental gases to your health.
The MkIII can be selectively used with a 9-volt battery and provided wrist strap, making it mobile for students studying in a library or travelling on a plane. It comes with a car mounting kit for cars and trucks. It has 32 medical settings.
Elanra Air Pendant from Bionic Air
Uniquely designed specifically for passengers in aircraft but can also be used whilst sitting in your office. The Elanra Air Pendant is a Portable registered medical device for clearing trace jet fuel fumes of the smallest unseen sizes and pathogens (viral and bacterial) from the air, whilst you are flying. The special battery is designed for airline acceptance and will last a 22 hour journey from Australia to London with a stop-over. The device has 9 medical settings.
Independently tested in the USA, the Elanra Air Pendant officially ‘clears Pathogens at the rate of ½ Litre per second within the space between your centre chest and your nose’. It is the only medical device in the world designed for aircraft travel. Elanra is compliant with required medical standards for EMC and electrical safety and will not interfere with aircraft instrumentation due to its uniquely defined space of treatment.
TGA 16988 – Stationary MkII Therapeutic Medical Devices
Australian Register of Therapeutic Goods
Official excerpt of our TGA registration “Intended Purpose”
To be used at home or in a hospital or clinic to produce small biologically active negatively charged ions of oxygen, pulsed at various selective frequencies that are emitted into the ambient air to be inhaled and ingested via the lungs into the bloodstream of the patient to produce a positive therapeutic or biological effect. For improved health and wellbeing, increased alertness, and to assist in recovery from illness and chronic fatigue. To reduce the severity and frequency of colds and flu. Support and assist in immune system recovery. Relieve the symptoms of seasonal conditions. Helps improve sleep and learning and assists allergy & eczema sufferers. Assists breathing by reducing airborne pathogens and dust. Used to normalise the body’s natural hormonal levels which have been altered by the increasing levels of positive ions in the ambient air, as well as enhance the body’s absorption of oxygen, vitamins B and C.
TGA 169886 – Portable MkIII and Air Pendant Therapeutic Medical Devices
Australian Register of Therapeutic Goods
Official excerpt of our TGA registration “Intended Purpose”
To be carried or worn when on the move, eg in cars, airplanes, hospitals or at home to produce small biologically active negatively charged ions of oxygen, pulsed at various selective frequencies that are emitted into the ambient air to be inhaled and ingested via the lungs into the bloodstream of the patient to produce a positive therapeutic or biological effect. For improved health and wellbeing, increased alertness when driving, and to assist in recovery from illness and chronic fatigue. To reduce the severity and frequency of colds and flu. Support and assist in immune system recovery. Relieve the symptoms of seasonal conditions. Helps improve sleep and learning and assists allergy & eczema sufferers. Assists breathing by reducing airborne pathogens and dust. Used to normalise the body’s natural hormonal levels which have been altered by the increasing levels of positive ions in the ambient air, as well as enhance the body’s absorption of oxygen, vitamins B and C.