I completely agree with Chaudhry.

According to an article I read regarding the Fitbit regulations decision with FDA, it said that, “According to FDA, the general distinction between a general wellness product and a medical device is whether the product makes a medical claim”.

the fitbit is clearly not intended for medical claims. It doesn’t tell claim that you have a certain health condition. It is just an aid device to track your overall fitness. If it had to be classified, I will go for classifying it as a class 2 device as there are similar devices intended to monitoring heart rate and clinical studies would be needed.

https://www.advisory.com/daily-briefing/2016/08/18/fda-says-it-wont-regulate-fitbit