Replies to post #26742 on Bioelectronics Corp (BIEL)

[zemun10]

I just received this in my e-mail. We can all start helping out.

Dear BIEL Shareholder,

You have a chance to get your voice heard on BioElectronics reclassification request for ActiPatch. The FDA is currently accepting public comments on our petition for reclassification of ActiPatch to Class II on the following website.

http://www.regulations.gov/ - !documentDetail;D=FDA-2012-N-0378-0003

Currently, ActiPatch is classified as a Class III device that may only be dispensed by or on the order of a licensed health care practitioner. Unlike many other regulatory agencies, the FDA has classified all pulsed shortwave therapy devices as high risk and Class III. The petition you are supporting asks for reclassification as Classs II that will allow us to sell directly to consumers in the U.S.

We’d you to share your opinion and/or your experiences as a user with the FDA. Below is a sample comment you can cut and paste into the web site. After filing a comment online please also write your US Senators and Representatives to let him or her know what you want so that they can also appeal directly to the Commissioner to support this reclassification of ActiPatch. You can find your Senators’ and Representatives’ contact information by using the following websites:

US Representative: http://www.house.gov/representatives/find/
US Senators: http://www.senate.gov/general/contact_information/senators_cfm.cfm

If you copy us at: [e-mail] and we will keep track of your comments and have them available to use in our meetings with the FDA. We remain confident that once the FDA understands the value of the ActiPatch Technology we will be able to resume sales within the US.

Sincerely,

Andrew J. Whelan
CEO and President

HOW TO COMMENT

Go to:
http://www.regulations.gov/ - !documentDetail;D=FDA-2012-N-0378-0003

Fill in the form with your own name and Organization. If you do not have an Organization to use say, “ActiPatch Customer”
Submitter’s Representative field is not required and you can leave it blank
Category field – choose the right one for you or scroll down to the last field, which is “individual consumer.”

Write whatever you want in the comment field or you can cut and paste the following into the Comment field

I am a shareholder of BioElectronics and I want the FDA to reclassify ActiPatch as a Class II device so that I can have easy and affordable access to this safe and effective product.

I have used ActiPatch to relieve (fill in your condiiton)

The results were (fill in your experience)

The FDA old classification does not fit ActiPatch because unlike the old PEMF systems, it is easy for a consumer to use, it uses low power – a watch battery and it is much more affordable.

Please reclassify this product to make it more accessible to consumers like me.

reclassify ActiPatch as a Class II device so that I can have easy and affordable access to this safe and effective product.

I have used ActiPatch to relieve (fill in your condiiton)

The results were (fill in your experience)

The FDA old classification does not fit ActiPatch because unlike the old PEMF systems, it is easy for a consumer to use, it uses low power – a watch battery and it is much more affordable.

Please reclassify this product to make it more accessible to consumers like me.