Bioelectronics Corp (BIEL)

[DewmBoom]

Check the update date Next to Device Classification Name by clicking below: 2016-8-29

http://google2.fda.gov/search?q=actiband&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&requiredfields=-archive%3AYes&output=xml_no_dtd&getfields=*

Now click on the more results below it and see this:
510(k) Premarket Notification, with an update on 10/3/2016

http://google2.fda.gov/search?as_sitesearch=www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm&q=actiband&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&requiredfields=-archive:Yes&output=xml_no_dtd&getfields=*&ie=UTF-8&ulang=en&&access=p&sort=date:D:L:d1&entqr=1&entqrm=0&wc=200&wc_mc=1&oe=UTF-8&ud=1

The 510K premarket notification has been modified on 10/3/2016. The Actiband has been accepted as a predicate after the reclassification for Actipatch, Allay and RecoveryRx. The Actipatch is going to be cleared by the FDA for OTC, hopefully on or before October 13, 2016, the reclassification anniversary and the trigger for enforcing the special control. The Big Bang is coming very very soon.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/ldetails.cfm?lid=209328