The Snuza Pico, Hero and Go are not medical devices. It falls into a similar class of device as exercise heart-rate monitors (the kind that has a strap around your chest and transmits your heart rate to a watch), but they only monitor movement (Pico monitors Skin temperature and Body position too). It should not be used to diagnose, monitor, treat or alleviate a disease, injury or handicap. Nor should it be used to investigate (i.e. find the cause of) a physiological process (i.e. breathing).
The Hero MD (Only available in Europe) is medically certified according to European Directive 93/42/EEC.