This device is not intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease.

This device is not intended for a medical purpose, including

  1. use by a health care professional;
  2. use in a health care facility or environment; and
  3. use that meets the definition of a device, (e.g., body temperature measurement for diagnostic purposes, including such use in non-medical environments)