What is a recreational oxygen concentrator used for?
If easing symptions of a physical / medical condition, of course it's a device.
If exercising, it
might be a medical device.
??
Per the Act, a device is:
- "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia, 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 any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."
Clause 3 of course is wide open to interpretation.
We do know, though, for instance, that an oxygen concentrator and gas separator for use in the blending of technical diving gases would not be a medical device. The preparation, concentration or pressurization of gases for breathing purposes, in and of itself, isn't inherently medical.
It depends on the product's use.