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I am new in the device industry and hope someone could provide advice on the following:
the device we have is a TEAS system and its intended use is for smoking cessation. From the device mechanics it seems to be a class iia device, however its intended use is questionable as a disease condition.
Can anyone advice me if this device of ours does comes across as a medical device and thus bounded by the device regulation?
the device we have is a TEAS system and its intended use is for smoking cessation. From the device mechanics it seems to be a class iia device, however its intended use is questionable as a disease condition.
Can anyone advice me if this device of ours does comes across as a medical device and thus bounded by the device regulation?
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