Medical devices are instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly in the human body, including required computer software; whose utility is obtained primarily by physical and other means, not by pharmacological, immunological, or metabolic means, or which, although involved in these means, play only an ancillary; and whose purpose is:
(i) the diagnosis, prevention, monitoring, treatment, or mitigation of disease;
(ii) the diagnosis, monitoring, treatment, mitigation, or functional compensation of injury;
(iii) the testing, substitution, modulation, or support of physiological structures or processes;
(iv) the support or maintenance of life;
(v) pregnancy control;
(vi) providing information for medical or diagnostic purposes through the examination of samples from the human body.