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Hiren Rana replied to the topic Fitbit: A Medical-Grade Device? in the forum Introduction to Project Management 8 years, 2 months ago
I agree with the majority of the people in that fitbit is not a medical device. It does not pose a risk to the user. It is intended for use in the diagnosis of disease or other conditions. The fitbit does not meet the requirements for a medical device. It does not aid in the diagnosis of a condition. The fitbit is basically a fitness tracker. To answer the question if hypothethically, the fitbit was considered a medical device it would probably be a class I device as it does not pose any risk or harm to the user. As with any class I device, it would have to go through the proper regulations for a class I device.