Class 1 devices are intended for devices that require general controls by the FDA. At home blood pressure monitors are considered a class 1 device. Although they are not intended to diagnose, people rely on these monitors to make sure their blood pressure is at safe normal levels between doctor visits. If a monitor was not regulated by the FDA it is possible that it malfunctions and gives inaccurate readings while still advertising 99 percent accuracy on the box. This would make it a class 1 measuring device because it is intended to measure a physiological factor and implies accuracy.

Fitbits allow people to monitor their blood pressure constantly throughout the day eliminating the need for another at home test. Given the fact that it is measuring physiological factors and implies accuracy it should also be a class 1 measuring device. If it’s not properly monitored people can be misinformed about their blood pressure or other physiological measurements which can accumulate into an issue over time.

Although they don’t explicitly make medical claims it is implicitly implied that the physiological monitoring is accurate.