Replies to post #75535 on Bioelectronics Corp (BIEL)

[uksausage]

but something was changed related to it on April 11th that is what was originally reported.

I don't believe Actiband was originally passed for OTC was it. it certainly was only Class 3

So the FDA databases were updated 9 days ago to update that record (which is public since it was cleared) to either mark it as Class 2 or as OTC, both of which were actions that the company can apply for as part of the reclassification and were "automatic".

It certainly is an indication that there could be a related decision since this is the predicate device for the main Actipatch application.

it is also in line with other timelines reported for 510k clearances