BioElectronics applauds US FDA recommendation to reclassify Shortwave medical devices to Class II

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BioElectronics Corporation, the maker of disposable drug-free healing pain therapy devices, has applauded the US FDA’s recommendations in their Docket No. FDA-2012-N-0378, “Physical Medicine Devices; Reclassification and Renaming of Shortwave Diathermy for All Other Uses”.

“We are pleased that the FDA is reclassifying this technology to reflect its safety and efficacy,” said Andrew J Whelan, president, BioElectronics.  “The FDA’s recommendation makes scientific evidence the determinant for additional market clearances.”

Whelan reported, “We will be responding to the call for new 510K applications with our extensive published clinical data and with new clinical trial data generated from, randomized, placebo controlled studies conducted at some of the world’s leading medical institutions.  We are confident that our scientific and clinical data will enable us to obtain equivalent US market clearances to those we have earned in Canada, the European Common Market and much of the rest of the world.”

“We are grateful to our customers and shareholders for their input to the FDA in the process that lead to today’s recommendation. US consumers need ready access to this safe, drug-free and cost-effective technology that offers superior pain relief and accelerates healing,” Whelan said.

BioElectronics is the leader in consumer medical devices that reduce pain, inflammation and accelerate healing. Its products are ActiPatch Musculoskeletal Pain Therapy for back, knee, and other musculoskeletal complaints; RecoveryRx for chronic and post-operative wound care; HealFast Veterinary Therapy, Allay Menstrual Pain Therapy and Smart Insole Heel Pain Therapy.

Source: PharmaBiz


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