Navigation Links
Axiom Worldwide Delists and Terminates US FDA 510(k)s for the DRX9000 Series of Products
Date:8/21/2012

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.

(Photo:  http://photos.prnewswire.com/prnh/20120821/CG60866)

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

News distributed by PR Newswire iReach: https://ireach.prnewswire.com


'/>"/>
SOURCE Axiom Worldwide
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. AspenBio Pharma Executes Worldwide License Agreement for its Animal Health Assets
2. BioMed Diagnostics Microbiology Diagnostic Devices Now Available Worldwide Through Distribution Agreement With VWR International, LLC
3. Mesenchymal Stem Cell Research Activity Rose 116% in 2011; Businesses Turning to BioInformant Worldwide for MSC Market Research
4. Chimerix Signs Worldwide License Agreement With Merck For CMX157, A Novel Candidate For The Treatment Of HIV
5. Misonix Exhibits at Major Worldwide Spine Conference
6. NicOx Signs Worldwide Licensing Agreement With Rapid Pathogen Screening, Inc. For Ophthalmic Diagnostics
7. Kansas City Region Launches Contract Research Initiative To Speed The Development Of Health Care Innovation Worldwide
8. Cephasonics Inks Distribution Deal With Tritech To Extend Worldwide Sales Reach Into Israel
9. Worldwide Multicenter Experiences with CardioFocus HeartLight® EAS to be Presented at Heart Rhythm 2012
10. Telemedicine Monitoring: Market Shares, Strategies, and Forecasts, Worldwide, 2012 to 2018
11. ResearchMoz: Telemedicine Monitoring Market Shares, Strategies, and Forecasts, Worldwide, 2012 to 2018 - Market Research Report
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... -- The Academy of Managed Care Pharmacy (AMCP) today ... allow biopharmaceutical companies to more easily share health care ... coverage decisions, a move that addresses the growing need ... The recommendations address restrictions in the sharing of product ... a prohibition that hinders decision makers from accessing HCEI ...
(Date:6/24/2016)... June 24, 2016 According to ... Type (Standard Pen Needles, Safety Pen Needles), Needle Length ... Growth Hormone), Mode of Purchase (Retail, Non-Retail) - Trends ... report studies the market for the forecast period of ... USD 2.81 Billion by 2021 from USD 1.65 Billion ...
(Date:6/23/2016)... HOUSTON , June 23, 2016  MedSource ... platform as its e-clinical software solution of choice.  ... the best possible value to their clients by ... nowEDC.  The preferred relationship establishes nowEDC as the ... pricing for MedSource,s full-service clients.  "nowEDC has long ...
Breaking Medicine Technology:
(Date:6/25/2016)... FL (PRWEB) , ... June 25, 2016 , ... The temporary closing of Bruton Memorial ... Plant City Observer , brings up a new, often overlooked aspect of head lice: the ... closing for fumigation is not a common occurrence, but a necessary one in the event ...
(Date:6/25/2016)... ... ... First Choice Emergency Room , the largest network of independent freestanding ... of its new Mesquite-Samuell Farm facility. , “We are pleased to announce Dr. ... James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , Dr. ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin Johnson has ... he has implemented orthobiologic procedures as a method for treating his patients. The ... first doctors to perform the treatment. Orthobiologics are substances that orthopaedic surgeons use ...
(Date:6/25/2016)... ... ... Conventional wisdom preaches the benefits of moderation, whether it’s a matter of indulgence ... high can result in disappointment, perhaps even self-loathing. However, those who set the bar ... from PsychTests.com reveals that behind the tendency to set low expectations is ...
(Date:6/24/2016)... Marne, Michigan (PRWEB) , ... June 24, 2016 , ... ... To deal with these feelings, many turn to unhealthy avenues, such as drug or ... Center of Marne, Michigan, has released tools for healthy coping following a traumatic event. ...
Breaking Medicine News(10 mins):