Based on your selections, your non-invasive medical device is Class Im.
Is your device active?
However, if your device is also active, you will need to continue below to check whether this results in a higher classification.
We recommend that you take note of the above result, as the higher classification of your two results is the correct classification for your device.
What is an active medical device?
An active medical device is intended by the manufacturer to:
- depend for its operation on a source of electrical energy or other source of energy (other than a source of energy generated directly by a human being or gravity), and
- act by converting this energy.
Active medical devices do not include medical devices that are intended by the manufacturer to transmit energy, a substance, or any other element between an active medical device and a human being without any significant change in the energy, substance or other element being transmitted.
Software that is a medical device is an active medical device.