Is an Athletic Muscle Stimulator a Medical Device in Canada?

#1
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":

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?
 

mihzago

Quite Involved in Discussions
#2
in my opinion, you have to consider the entire sentence in (b)
... restoring, modifying ... or the functioning of any part of the bodies.

so it would appear that if you "promote circulation", or other claims that you make, would fall under medical device functionality.

What I would do is search the database of Establishment Licenses and Medical Device Licenses (separate databases) to see if there are similar products registered with Health Canada.
You can also send the request for help with classification to device licensing (device_licensing@hc-sc.gc.ca). Unlike the FDA, Health Canada will actually work with you informally without any special pre-subs or formal classification requests (at least that was my experience).
 
#3
in my opinion, you have to consider the entire sentence in (b)
... restoring, modifying ... or the functioning of any part of the bodies.

so it would appear that if you "promote circulation", or other claims that you make, would fall under medical device functionality.
I'd interpreted it as:
"restoring...the functioning" or
"modifying...the functioning" or
"correcting...the functioning"

Which, in my opinion, such a stimulator does none of, lest a hot-water bottle or ice-pack be deemed medical devices in that they affect circulation as well...

Thanks for the contact, I'll check them out...
 

mihzago

Quite Involved in Discussions
#4
You must consider not only the design, but also the claims you're making. There are many simple everyday products, or some more complex like heart rate monitor or pulse ox, that may or may not be considered a medical device based on the claims.

In the US, an ice pack/bag is actually a class I medical device (product code KYR)
 
#5
In the US, an ice pack/bag is actually a class I medical device (product code KYR)
Crikey! ...they really are in the business of regulating everything. :nope:

...but I guess that's a logical outcome of a definition as vague as "affect the structure or any function of the body".
 

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