Definition of medical device: medical device means 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 a supplementary role; whose purposes are:
(i) disease is diagnosed, prevented, monitored, treated, or palliated;
(ii) injury is diagnosed, monitored, treated, palliated, or functionally compensated for;
(iii) physiological structure or physiological process is examined, replaced, regulated, or supported;
(iv) life support or maintenance;
(v) pregnancy control;
(vi) the provision of information for medical or diagnostic purposes through the examination of samples from the human body.