Bioelectronics Corp (BIEL)

[Simpsonly]

Great find wyatt
The use of the words "applying therapeutic deep heat" is now passé, given that heat is not part of the accepted vernacular now. . . . .

Causes me to wonder, is this representative of a new 510(k) application by a manufacturer or a re-publishing or an amendment of something now obsolete?

It also states clearly "Class 2", so who the hell knows what?
It also states "Physical Medicine and Neurotherapueutic Devices Branch (PNDB)", how does that relate to CDRH? Is PNDB a sub of CDRH? 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?

I have long wondered if BIEL could possibly gain a leg up, as it were, by applying for all sorts of approvals, by whatever means, prior to the issuance of the new Order establishing the new classification, thereby gaining any time.

And what entity, if any, made the 510(k) application, or is this to indicate the pathway in future? At best, the material triggers more questions.