kid, I originally thought this as well when I wrote that post. I went back and reviewed some things, and emailed Paul and realized I may have been in error.
The original version of the Allay and Acti had a lower power output and did not produce the amount of heat that the new version does. I think what happened was that BIEL identified a IMJ device as a predicate; of course the NSE came because, I think, the power output was too low, not enough measurable heat, thus the rejection as it was NSE to a thermal device (It would be classified as non-thermal, class III). The proper predicate would have been the Class III, non-thermal device. But that's Class III, not what BIEL wanted.
So, BIEL went back to the drawing board, and designed a new, higher powered version of both products, which did meet the threshold for the definition of 'thermal'(apparently this is 0.3C to be physiologically beneficial - not sure where that number came from though). They submit this new device under the De Novo and hope that the IMJ product code applies.
For whatever reason, even if their power output is higher than the lowest setting on an already cleared IMJ device (doesn't matter how many, they only need to be greater than 1), the device is still considered non-thermal.
If the above is the actual case, it is completely mind-boggling to me that a device that has a greater thermal output than an already classified 'thermal' device is classified as 'non thermal'.
Now, could BIEL have gone about it differently? Absolutely. Get is approved for Class III, start selling it as a prescription device, and go from there. But if BIEL wanted Class II clearance, quick, then this was the only way to get there.
Is this a desperate move? Well, I think the entire thing about modifying the device to emit heat to get into a different product code is a little bass-acwards, but hey, this is business and this is the FDA they are dealing with.
A lot of things they do are backwards.
