Bioelectronics Corp (BIEL)

[tjshooker]

The FDA letter for clearance...http://www.accessdata.fda.gov/cdrh_docs/pdf2/k022404.pdf

To get anyone up to speed on the FDA...They cleared the ActiBand because it was "substantially equivalent" to an approved device, that was in 2002.

Then over the years, as BIEL tried to get other devices cleared for Rx and OTC, the FDA said they were "Not Substantially Equivalent" to any predicate devices. Including apparently, the device the FDA had already approved. They also felt that BIEL's products did not fit into either existing PEMF product codes (IMJ,ILX) because it was not "Short Wave Diathermy" it was considered "Non-Thermal Diathemy". Which literally means "not produced by heat, electrically produced heat". Seriously. That makes sense, right?!?
Despite having a product that is effective and safe, BIEL was stranded essentially, with no path to OTC clearance.

Last year (FEB. 2014) the FDA "on their own accord" wink, wink...proposed a rule change to make a category and pathway to OTC for BIEL and others with similar newly coded "Short Wave Therapy" devices.
If the FDA ever gets around to making it a final rule, this should really correct the current contradicting product codes.