All this talk of the device being approved by the FDA baffles me.  The FDA has no jurisdiction in Canada.  What does Health Canada have to say abou this?  Has this device been licensed by Health Canada?

For the record, what the earlier reviewer says about the FDA approval process is correct.  Health Canada, however, subjects the application for a medical device license to an extensive review process by evaluating safety and efficacy.  Start advertising that the Health Canda has approved this device for sale/use in Canada, and I might consider it.