This is the response from thermedic. A little over my head, but sounds like it meets the FDA’s criteria for FIR.
I want to explain to you about far infrared, the wavelength of far infrared are between 5.6-1000 μm . As far as the human body is concerned, the wavelength is most obvious at 5-14μm.
In practice, the SGS S.A testing environment of far infrared is between 2-22μm, in degree 25°C to test the emissivity will over 0.8 or not. Our products have been tested by SGS S.A and the emissivity over 0.8, with an average of 0.9 above.
So, it will be more realistic and useful to understand its emissivity, and our products have reached the standard, even exceeded, and the medical products must be sent to the US FDA for inspection ,and it can be listed on Amazon. So you can rest assured to use our products.