In my opinion the Fitbit should be classified as a Class 1 device as similar device exist in the market. This will help decrease the testing period as their are similar devices that prove that such devices are safe and of low risk.

Ashley, I checked the FDA website to answer your question, and it turns out that the Fitbit has surprisingly been classified as a Class II device!

https://www.accessdata.fda.gov/cdrh_docs/pdf13/K133872.pdf

Any thoughts anyone on why it has been classified as a Class II device?