SMARTfit is classified as a fitness device rather than a medical device for the following reasons: 

Activities chosen from the SMARTfit list of activities and programs rely on the trainer/therapist to decide which of them is appropriate and suitable for their clients.

Simply putting it, as in the case of using a treadmill or weight machine, a trainer/therapist needs to know whether the equipment, it’s user options or programs are suitable for the client before use.  Further, knowing the client’s capability will be essential to how the treadmill or weight machine is used.

However, SMARTfit is a non-invasive fitness device so it is not going to put the person at risk as a treadmill or weight machine would. That said, the trainer still needs to know whether the client should be doing seated only program, standing programs or moving programs.

SMARTfit incorporates programming and activities for all levels of ability but the trainer/therapist must assess their client and decide which ones are a suitable match for the client.

Since SMARTfit is NOT a medical device, it will never diagnose and treat people. Rather, it is a tool for the trainer/therapist to use to train their clients. For this reason, there is no need for risk assessment as you would normally find with a medical device.