News  |  November 6, 2006 Press Release

Eco-Rx Receives 510(k) Approval From the U.S. Food and Drug Administration for the RX-400 Air Purifier


NORTH MIAMI BEACH, FL--(MARKET WIRE)--Nov 6, 2006 -- Eco-Rx (Other OTC:ERXX.PK - News), producer of proprietary air purification products, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration for its RX-400 air purifier. The RX-400 purifies the air in a commercial or residential setting by drawing the air into its sealed chamber, exposing contaminants to three powerful UV-C lamps. Each RX-400 unit will clean a room up to 2500 cubic feet 5 times per hour. The 510(k) clearance allows the company to immediately begin marketing the device as a medical ultraviolet air purifier for the inactivation of indoor airborne bacteria.

A person or company who wants to market Class II devices intended for human use in the U.S. must submit a 510(k) to the FDA before marketing. The 510(k) is a pre-marketing submission made to FDA (U.S. Food and Drug Administration) to demonstrate that the device to be marketed is laboratory tested, safe, effective and properly labeled. Upon approval, it can be legally marketed as a Class II medical device in the U.S.

Paul Taccini, President of Eco-Rx, commented that "the Company sees a large need for products utilizing its patented technology in a number of different categories. This translates into a huge market opportunity for Eco-Rx. We have just completed the development of a smaller companion unit for the RX-400. Tooling will begin shortly with product introduction scheduled for mid-2007."

Eco-Rx is now positioned to pursue an aggressive campaign with key distributors dealing in durable medical and health care equipment. Certification as a Class II Device provides a number of benefits to Eco-Rx:

  • Important to healthcare professionals and decision makers in the institutional market. Lends creditability to the technology, simplifying the approval path for biomedical engineers in hospitals.
  • Increases comfort and credibility in institutional and consumer markets that the RX-400 is being used in hospitals, nursing homes, clinics and physicians' offices.
  • Separates our product from non-certified air purifiers, enhancing marketing and sales opportunities.
  • Certification will be necessary for insurance reimbursement if the product meets insurance code criteria in the future.

Previous independent testing by an EPA and FDA certified laboratory has confirmed that the unique technology found in the RX-400 kills airborne bacteria including: Bacillus subtilis, Pseudomonas aeruginosa, Staphylococcus aureus and Klebsiella Pneumonia.

About Eco-Rx
Eco-Rx, Inc. produces proprietary products utilizing high-intensity ultraviolet radiation (UVC) inside a "killing chamber" (a replaceable cartridge). The UV destroys airborne bacteria. Extensive independent testing by an EPA and FDA certified laboratory confirms that the unique technology kills airborne bacteria including: Bacillus subtilis, Pseudomonas aeruginosa, Staphylococcus aureus, Klebsiella pneumonia. The machine does not produce or use ozone. Eco-Rx combines its purification technology, a sophisticated electronic ballast system, with an electronic control module in a product that is totally effective and user-friendly. The technology uses a replaceable cartridge providing 12 months of continuous operation (24/7).

Disclaimer
This press release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include expectations which involve risks and uncertainties that could cause actual results to differ materially from results expressed or implied by these statements. Factors that might cause or contribute to such differences include, but are not limited to: difficulties encountered in launching a new product, competition and receiving timely shipments from the manufacturer in China. Eco-Rx undertakes no obligation and does not intend to update these forward-looking statements to reflect events or circumstances occurring after this press release. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement.

Press Contact: Joseph Peiken +1.305.937.1862

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