A diagnostic or therapeutic article that does not achieve any of its principal intended purpose through chemical action within or on the body. Such devices include diagnostic test kits, crutches, electrodes, pacemakers, arterial grafts, intraocular lenses, and orthopedic pins or other orthopedic equipment.
A diagnostic or therapeutic article that does not work by chemical action. Examples include diagnostic test kits, pacemakers, arterial grafts, intraocular lenses, etc..
an instrument, apparatus, implement, machine, contrivance, implant, in
an instrument or apparatus and parts and accessories used to diagnose, cure, mitigate, treat or prevent disease in man or animals
a product that also is intended to affect the structure or function of the body, but which does not achieve its primary intended purposes through the chemical action of a drug--nor is it dependent on being metabolized
Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of: (a) diagnosis, prevention, monitoring, treatment or alleviation of disease; (b) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; (c) investigation, replacement or modification of the anatomy or of a physiological process; (d) control of conception; and which does not achieve its principle intended action in or on the human body by pharmacological; immunological or metabolic means, but which may be assisted in its function by such means.
An article, instrument, apparatus or contrivance, including a component, part or accessory of one, that is manufactured, sold or represented for use in: (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in a human being; (b) the restoration, correction or modification of a body function or the body structure of a human being; (c) the diagnosis of pregnancy in a human being; or (d) the care of a human being during pregnancy and at and after the birth of a child, including the care of the child. It includes a contraceptive device but does not include a drug.
any product which is intended to correct a medical condition, is used in the treatment or diagnosis of a medical condition, or is intended to affect the structure or any function of the body; does not achieve its effect through chemical action.
any article, instrument or apparatus manufactured, sold or represented for use in:-the diagnosis, treatment, mitigation or prevention of disease, disorder or abnormal physical state or its symptoms in humans,-restoring, correcting or modifying a body function-the diagnosis of pregnancy, or-the care of human beings during pregnancy and at and afterbirth of the offspring, and includes contraceptive devices.
(MEH-dih-kul dee-VICE) An instrument, tool, machine, test kit, or implant that is used to prevent, diagnose, or treat disease or other conditions. Medical devices range from tongue depressors to heart pacemakers and medical imaging equipment.
Diagnostic or therapeutic article that does not work through chemical action, such as a diagnostic test kit.
An instrument, apparatus, implant, etc., which achieves its principal purpose through physical action, within or on the body and which is not dependent on being metabolized for the achievement of its principal intended purpose. The primary differentiation between a device and a drug are the words "chemical action" and "metabolized."
