NORTH MIAMI BEACH, Fla., Jan. 24 /PRNewswire-FirstCall/ -- Eco-Rx , producer of proprietary air purification products utilizing high-intensity ultraviolet radiation (UVC), began third party testing of its Model Rx 400 to attain FDA certification as a Class II Device. Previous independent testing by an EPA and FDA certified laboratory has confirmed that the unique technology found in the Rx 400 kills airborne viruses and bacteria including: Bacillus subtilis, Pseudomonas aeruginosa, Staphylococcus aureus, Klebsiella Pneumonia. In fact, anything with DNA or RNA is killed or neutralized. The machine does not produce or use ozone.
The Company is using third party testing in order to accelerate the overall certification process. Eco-Rx is fortunate that the product category allows it to be part of the FDA Third Party Review Program. This program was established in 1996 to improve the efficiency of the agency's review of low to moderate risk devices. On the average, 510 (k)s reviewed by third parties received marketing clearance 30% faster when compared to direct FDA review. As such, the Company anticipates the review will take less than 90 days to complete. The Third Party Reviewer for Eco-Rx is Intertek Services of Boxborough, MA. Intertek Services is an affiliate of Intertek Testing Services headquartered in Cortland, New York.
Certification as a Class II Device provides a number of benefits to Eco-Rx:
It is important to healthcare professionals and decision makers in the institutional market as it lends creditability to our technology and simplifies the approval path for biomedical engineers in hospitals. It will increase comfort and credibility in consumer and institutional markets that the Rx 400 is being used in hospitals, nursing homes, clinics and physicians offices. It separates our product from non-certified air purifiers enhancing marketing and sales opportunity. Certification will be necessary for insurance reimbursement IF our product meets insurance code criteria in the future.
Examples of Class II devices include powered wheelchairs, infusion pumps, and x ray machines.
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.
Eco-Rx, Inc.CONTACT: Joe Peiken of Eco-Rx, Inc., +1-305-937-1862
Web site: http://www.eco-rx.com/
