TAMPA, Fla., Aug. 21, 2012 /PRNewswire-iReach/ -- On August 20th, 2012, Mr. James Gibson, President & CEO of Axiom Worldwide, Inc. offered further clarification regarding the status of Axiom's US FDA 510(k)s. Although Axiom Worldwide, Inc. still maintains ownership of its Intellectual Property, specifically the 510(k)s, Axiom discontinued manufacturing operations in the USA but did not sell or transfer the 510(k)s; therefore, in accordance with the Federal Laws governing Medical Device Manufacturers, and as required by the US Code of Federal Regulations, Axiom took the required legal steps necessary to delist and terminate the DRX9000 series of devices to prevent any counterfeit manufacturing of these products worldwide. It was confirmed on April 29, 2011 that the FDA was in receipt of the filings by Axiom. The delisting and termination was further confirmed in July of 2012 when Mr. Gibson gave several days of testimony to federal investigators of the US FDA. These required FDA device delistings of 510(k) cleared devices are done in an effort to protect unsuspecting hospitals and doctors from purchasing illegal equipment not covered by an authentic 510(K), and more importantly, to protect the safety of consumers.
According to the US Food Drug and Cosmetic Act, a 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device. Under Section 510(k) of the Act, a company that wants to market in the US, a Class I, II, and III device intended for human use, for which a Premarket Approval (PMA) is not required, must submit a 510(k) to the FDA prior to commercial distribution. Federal law prohibits the commercial distribution of products such as the DRX Series of non surgical spinal decompression devices without a 510(k) clearance or an authentic and proper US FDA 510(k).
Axiom Worldwide Inc. continues to maintain the 510(k)s were not transferred to Excite Medical or HTRD and has informed the FDA of these facts, providing a recent court ruling on July 18th, 2012 from the Federal Court in Tampa, Florida, USA making a recommendation that ruled AGAINST HTRD and Excite Medical and their alleged ownership of the Axiom Intellectual Property, "…the factual record which demonstrates that HTRD does not own any of the trademarks or other intellectual property at issue...".The FDA has the authority to make a determination of whether such a medical device has been marketed illegally without an authentic 510(k) making device(s) potentially unsafe, and, the FDA can subject illegal medical devices to recall. If you are considering purchasing or have purchased a device from the DRX series after April 29, 2011, consider confirming the legal owner of the 510(k) clearances.
Mr. James Gibson is the sole founder of Axiom Worldwide, Inc and continues to serve as its President and CEO. Axiom Worldwide was created in 2000 in Tampa, Florida and obtained multiple US FDA 510(k) clearances over the years. Axiom Worldwide invented its flagship products, the DRX9000 True Non-surgical Spinal Decompression System and the DRX9000C, for use in medical markets around the globe. For more information please visit the Axiom Worldwide website at www.AxiomWorldwide.com or for more information on the 510(k)s or related court proceedings, contact Mr. James Gibson directly at President@AxiomWorldwide.com.
Media Contact: James Gibson Axiom Worldwide, +1-813-321-7414, President@AxiomWorldwide.com
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|SOURCE Axiom Worldwide|
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