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BioElectronics Presents FDA Reclassification Panel
Date:5/21/2013

ily available.   Whelan reported that BioElectronics has over-the-counter clearance from health agencies in 40 countries around the world.

Recent studies have demonstrated a clear mechanism of action for pulsed shortwave diathermy.   Whelan was assisted in the explanation to the panel by a researcher from the State University of New York in Binghamton, Sree Koneru .   Working at the Department of Bioengineering at the Watson School Koneru's experiment demonstrated the activation of motor nerves with non-thermal RF diathermy.

The hierarchy of nerve firing tells us that the initial response to the stimulus is sensory nerves activation. We now know that BioElectronics devices stop pain though well established and understood electrical nerve stimulation.  The effect is achieved through a proven physical phenomenon of stochastic resonance.  This demonstrated physiological mechanism of action is a major breakthrough for shortwave therapies that are considered non-thermal by the FDA.

There is significant public support for Whelan's position.  As part of its stakeholder review process, the FDA received 248 comments asking the FDA to reclassify ActiPatch to an over-the-counter class.[ii]   http://www.regulations.gov#!documentDetail;D=FDA-2012-N-0378-0003

About BioElectronics Corporation

BioElectronics Corporation is the maker of ActiPatch® Therapy, over-the-counter treatment for back pain and other musculoskeletal complaints, RecoveryRx(TM) Devices for chronic and post-operative wound care, HealFast®Therapy (www.healfasttherapy.com) and the Allay(TM) family of inexpensive, disposable drug-free anti-inflammatory devices. For more information please see ht
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SOURCE BioElectronics Corp.
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