From what I am reading I would assume that if the Pulse device was dependent on the software to gather generated data points and convert that data into some form of readable measurement and the software was an integral part of the device itself then it would be classed as a “Device - MDDS”.
As it is software on a smartphone that doesn’t interfere with the hardware function then it is a non-device? And therefore the device itself will not depend on the regulation of the app.
just my opinion.
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