Bioelectronics Corp (BIEL)

[Simpsonly]

My previous post:
And clik on Sec. 890.5290, although it also refers to heat, the power output range is what BIEL falls into and it definitely states Class 2, so what gives? Are they coming sideways at establishing the new Class II designation? That would seem out of accepted practice for the FDA to do this, could it be an error and some entity is applying in advance?

As I said it refers to heat, BUT, the actual wording is "other than" in referring to the heat aspect. This is under the new protocol for PEMF / SWT devices where the heat treatment modality has been dropped, so what's up? Is someone indeed coming at this sideways, like an end-run?