An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is

• recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them;
• intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or
• intended to affect the structure or any function of the body of man or other animals and which does not achieve its primary intended purposes through chemical action or metabolism within or on the body.