You can add this to the its about time file.The FDA will regulate wearables making health claims. It seems that everyone is putting on a smartwatch to be healthier. However these device are not serious medical devices. The distinction is very important and should be regulated by the FDA. Seems the FDA agrees with this line of thought as well.
While the FDA has not made this legally binding. The agency has published a draft guidance note. The FDA is also taking opinions from the public. The FDA says general wellness devices such as Fitbit are not any risk to the public. That said, if a product that promises to treat any medical issues. That is a problem. If it says it will help treat obesity to erectile dysfunction or anything in between the FDA will have to confirm that.