I agree that this should not be classified by the FDA because it does not pose significant risk to the user. The fitbit is an extracorporeal device that is non-invasive and it a general wellness product, like the individual above me has already said. I’d like to expand by also saying that there are other general wellness wearable smart devices currently in the market, so it’s not as if the fitbit is the only product to do what it does. If the fitbit is un-calibrated, than that should be brought up with the manufacturer as that is a consumer issue.

If it were classified by the FDA, I would classify it as a class I because similar devices already exist in the market and it could easily be classified by the FDA as being safe and low-risk based on the devices already approved. Clinical trials would not be required in this case as the device does not pose a significant enough of a risk to warrant doing so.