I'm uncertain how a battery-powered, over-the-counter, consumer athletic muscle stimulator intended for massage, promoting circulation following exercise, supplementing muscle workouts, etc. is classified in Canada.
In other regions it would appear to be classified as a medical device. For example, under the US FDA definition of a "Medical Device":
such a device would appear to be classified as a medical device...
But in Canada (Food & Drugs Act F-27), the definition reads:
...which I'm a little more uncertain as to whether this applies.
I guess it would depend on the interpretation of the terms "restoring" and "modifying" body structures.
Any advice as to how to interpret this? Would you consider it a medical device?
In other regions it would appear to be classified as a medical device. For example, under the US FDA definition of a "Medical Device":
US FDA
an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is...intended to affect the structure or any function of the body of man or other animals...
such a device would appear to be classified as a medical device...
But in Canada (Food & Drugs Act F-27), the definition reads:
device means an instrument, apparatus, contrivance or other similar article, or an in vitro reagent, including a component, part or accessory of any of them, that is manufactured, sold or represented for use in...(b) restoring, modifying or correcting the body structure of human beings or animals or the functioning of any part of the bodies of human beings or animals
...which I'm a little more uncertain as to whether this applies.
I guess it would depend on the interpretation of the terms "restoring" and "modifying" body structures.
Any advice as to how to interpret this? Would you consider it a medical device?