TAMPA, Fla., March 26, 2013 /PRNewswire-iReach/ — Axiom Worldwide, Inc. has verified through official correspondence from the United States Food and Drug Administration that neither Excite Medical in Tampa, Florida or HTRD Group in Hong Kong own any 510(k) clearances for any DRX system. This determination by the FDA in a July 2012 Establishment Inspection Report (EIR) appears to be in direct conflict with the various press releases issued by Mr. Saleem Musallam and Ms. Livia Fernandes of Excite Medical, and Mr. David Ren of China and HTRD Group of Hong Kong.

In Axiom’s ongoing efforts to provide up to date and accurate information to the global healthcare community, an official Freedom of Information Act (FOIA) request was submitted to the FDA for all correspondence relating to Excite Medical’s compliance with FDA regulations and requirements. Included in the FDA’s response to the FOIA request as the July 2012 FDA Establishment Inspection Report (EIR) that not only highlighted the deficiencies in Excite’s Quality Systems, but more importantly identified a glaring fallacy contained in their marketing communications.

The EIR listed two specific statements by the US FDA Federal Investigators regarding the existence of any 510(k) clearances for Excite Medical and/or HTRD Group:

1. “We searched the FDA 510(k) Premarket Notification website and could not find any 510(k)s registered to Excite Medical Corp.”

2. “Our search of 510(k) submissions did not show any 510(k)s associated with Excite Medical Corp or HTRD Group Hong Kong, Ltd. for the DRX5000 and DRX9000 devices assembled by Excite Medical.”

However, a March 31, 2011 Press Release issued by Ms. Livia Fernandes, Vice President of Excite Medical, states that in December 2010 “The United States Food and Drug Administration transferred legal ownership of the (Axiom) 510(k)s.”. To date there is no verified documentation to suggest that there was a valid transfer of Axiom’s Inc. 510(k)s to Excite Medical or HTRD. In essence, without either a valid submission or evidence of a legal transfer of a 510(k), then it may be a violation of federal law for anyone to manufacture, market and sell such a device. Because these devices can potentially be considered adulterated and illegal, the FDA has the authority to subject any medical devices determined to be illegal to recall.

Axiom Worldwide, Inc was founded by Mr. James Gibson in 2001 in Tampa, Florida and obtained multiple US FDA 510(k) clearances over the years. Axiom invented its flagship product the DRX9000 True Non-surgical Spinal Decompression System and the DRX9000C for use in medical markets around the globe. The DRX 9000 and the DRX9000 C were created to provide relief of back and neck pain and symptoms associated with herniated discs, bulging or protruding intervertebral discs, degenerative disc disease, posterior facet syndrome, and sciatica.

Please contact Mr. James Gibson, President and CEO of Axiom Worldwide, Inc for more information at President@AxiomWorldwide.com For more news updates, visit www.AxiomWorldwide.com and click on the News link.

Media Contact: James Gibson Axiom Worldwide, Inc., (813) 321-7414, president@axiomworldwide.com

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SOURCE Axiom Worldwide, Inc.