According to the FDA the fitbit is classified as class II. It’s funny, something so small such as a fitbit runs on algorithm has to be regulated and considered to be a class II. During my capstone project we also programmed accelerometer that could count a patient’s steps and we wrote an algorithm that could tell the user if they are walking normal or abnormal. After looking classification for our accelerometer, we found out that devices like these are considered class II. It is because, like the fitbit it needs to be clinically tested before it hits the market. In my opinion it makes sense, you do not want to buy a device that gives you the wrong data if you are working out. What’s the point.

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm