Medical device, refers to 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 the required computer software; its utility is obtained mainly through physical and other means, not through pharmacological, immunological or metabolic means, or although these modalities are involved but only in an ancillary manner; and which are intended for:
(i) diagnosis, prevention, monitoring, treatment, or mitigation of disease;
(ii) diagnosis, monitoring, treatment, mitigation, or functional compensation of injuries;
(iii) testing, substitution, modulation, or support of physiologic structures or physiologic processes;
(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.