Bioelectronics Corp (BIEL)

[Simpsonly]

I may be completely on the wrong path here and would appreciate help understanding som edue diligence and research.
On the FDA website there is a page of "Medical Devices Cleared or Approved by FDA"

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm335803.htm

There are links on the left for each year.

At the top there is a link entitled: Recently Approved Devices and on there it states:
Recently-Approved Devices
Recently-Approved Devices: Get e-mail updates 1
The products listed in this section include some of the newest medical technology available. The products in each list contain information about what medical uses the device is cleared or approved for, when it can be used, and when it should not be used. This information, along with information from your doctor and other sources, can help make you an informed participant in your health care.

Please note: The lists in this section do not include every approval. Complete lists of different approval activities can be found in the following sections:
• PMA Approvals2: New or high-risk medical devices that require a more rigorous premarket review than the 510(k) pathway.
• 510(k) Clearances3: New devices that are "substantially equivalent" to a device that is already legally marketed for the same use.
• Humanitarian Device Exemptions (HDE):4 Devices that treat or diagnose a disease or condition that affects fewer than 4,000 individuals in the United States per year.

My predicament - I can’t for the life of me understand why the company didn’t simply request or apply for approval under a 510K given that ActiPatch and ALLAY are exactly the same system as RecoveryRx which had already been approved for sale by prescription and at least get the products on the market in the US and apply for OTC later. And if that was doable then but management screwed up, why not do it now?

Also, I noted that in 2012, month by month, there were device approvals numbering from January – 4, 9, 3, 5, 3, 3, 4, 1, 4, 8, 4, and 1 in December.
However, in 2013 approvals or clearances number 1 in January, zero in February and zero so far in March. Is this indicative of the ‘device’ turmoil at FDA and the Administration simply trying to catch up in a new sector where really skilled people may be in short supply? The numbers seem low considering what I expect would be many thousands of applications for approval or clearance of devices by companies from all over the world.