Your are partly correct. There are multiple classifications for medical devices. CPAPs are class 2 devices whereas a pacemaker is class 3. I don’t want to ove

Your are partly correct. There are multiple classifications for medical devices. CPAPs are class 2 devices whereas a pacemaker is class 3. I don’t want to over simplify, so I will link you to the FDAs entry point into the Byzantine maze of classifications. https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device https://www.fda.gov/medical-devices/overview-device-regulati...