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williamzembricki replied to the topic Fitbit Medical Device? in the forum Introduction to Project Management 7 years, 4 months ago
The new generation of smart watches does make it a slight bit confusing about whether or not they should be considered a medical device. The device does not monitor blood pressure but it does attempt to monitor the wearers heart rate. It provides data from the day/wee/work out about where your heart rate was. The device does seem to fit the definition of a class one medical device and it should be treated as so. These devices can cause people to feel comfort about their heart rate, but if the reading is incorrect someone could be having a serious heart condition and be given a false sense of comfort from the watch saying they are okay. These devices are claiming to be able to take a medical reading of a person’s heart rate and should be held to these medical standards. These devices are clearly not a blood pressure cuff or a xray machine but they are a form of monitor the general health. The sensors on a treadmill are considered a medical device and so should the watches.