The InfraMat Pro
October 11th, 2017
The thing is, and this is where we once again veer into the science-fiction genre, the product’s marketer, Healthy Line, does not possess the required scientific evidence to make such disease-treatment claims. While there’s the implication on the marketer’s website that the InfraMat Pro is “FDA registered,” (see below) it is the company, not the product, that has registered with the FDA. Moreover, to be “FDA registered” is not some prestigious thing; it is a requirement of all companies that market medical devices. To put it another way, it’d only be news if the company wasn’t registered.
In truth, Healthy Line did not have to demonstrate to the FDA that the InfraMat Pro is at all safe or effective before selling it to the public because the powered heating pad falls under a category of medical devices that are exempt from premarket notification procedures. Other similar products that fall under this category include infrared lamps and heat packs.
There is, however, one interesting tidbit of information on Healthy Line’s registration listing — which TINA.org tracked down after a Healthy Line customer service representative provided the company’s registration number in an online chat — that is worth mentioning: Despite claiming on individual product pages that it is a “USA company,” the listing identifies a Chinese company as the sole “owner/operator.”
Healthy Line is not the first to pitch salvation from ailments via magic stones but hey, at least with the InfraMat Pro you don’t have to stick it in your nether regions like Goop’s famous/infamous yoni eggs.
To learn more about TINA.org’s coverage of medical devices, click here.