Sec. 6. As used in this chapter, "medical device" refers to an instrument, an apparatus, an implement, a machine, a contrivance, an implant, an in vitro reagent, or another similar or related article, including a component part or accessory:
(1) that is recognized in the official National Formulary or the United States Pharmacopoeia, or any supplement to them;
(2) that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in a human being or an animal; or
(3) that:
(A) is intended to affect the structure or any function of the body of a human being or an animal;
(B) does not achieve its primary intended purpose through chemical action within or on the body of a human being or an animal; and
(C) is not dependent upon being metabolized for the achievement of its primary intended purpose.