Replies to post #21510 on Bioelectronics Corp (BIEL)

[Johny37939]

Great post fuente. I agree whole heartily and a lot of things they do are backwards. Like tell the company that the device isn't a thermal device and then when they make it, the FDA decides it still isn't a thermal device. Oops, they didn't see the change. IMHO the FDA is full of puppets under big pharma control and I've wrote my representatives and aired my belief to a few news agencies. I just hope enough concerned citizens do the same and it creates a serious change within the FDA.

[kidnova]

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.

The problem with this strategy, in my opinion, is that BIEL has been marketing this device as a PEMF product for years. Their previous clearance on a different version of the device was as a non-thermal diathermy device. As far as I'm aware, every PEMF device to date has been classified as a class III device. They intend to market it based on the benefits of PEMF do they not? How can they now turn around and say "well, it's really more like icy hot than a PEMF device, will you clear us now?" I find it hard to believe that the FDA is going to fall for that attempt to skirt the regs.