Before answering this question, let’s understand the definition of medical device as defined by Singapore Health Science Authority (HSA):
A medical device is a product or equipment intended for medical use, such as to diagnose, monitor or treat diseases, or as a supportive aid for people with physical disability. While many medical devices such as x-ray machines, dialysis machines, infusion pumps and cardiac pacemakers are used by doctors, nurses, and other healthcare professionals to help them diagnose and treat patients in hospitals or clinics, there are also a number of medical devices that are used by the patients, care givers and public in the home setting. Examples of common medical devices that you may use in your daily lives include wound dressings, digital thermometers, contact lenses and wound irrigation solutions.
Products such as body toning equipments, magnetic accessories and massagers, are not medical devices. These products are only intended for general well-being and do not prevent, diagnose, treat or alleviate injuries or diseases.
Purpose and Intended use of Omnium1 System
With the Omnium1 magnetic resonance stimulation system, weak, pulsating electromagnetic fields are used to activate various physiological processes in the body by improving the cell membrane potentials through accelerated ion transfer. This occurs through resonance effects triggered by the magnetic field pulses. The strength of these magnetic fields is no stronger than the average magnetic flux density of the Earth’s own magnetic field.
The Omnium1 resonance stimulation system can be used for the purpose of:
- Overall Well-being
Is Omnium1 a Medical Device?
So in short – Omnium1 is NOT a medical device. If there is any doubt in its use, please contact us for further information. As each country’s definition of medical device may have some minor difference, the above statement may not be applicable to all countries.
← Is Omnium1 a medical device?