NORTH MIAMI BEACH, Fla., Jan. 18 /PRNewswire-FirstCall/ -- Shortly, Eco-Rx (OTC Pink Sheets: ERXX) will begin the 510(k) submission process with the FDA to list its Rx 400 as a Class II Device. To expedite this process, the submission will be made using the third-party review process.
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.
Eco-Rx's president, Paul F. Taccini, said, "FDA certification is an important step for the Company in gaining recognition that its technology is on the leading edge and a significant advance over existing technologies. Few consumer-oriented air purification products are FDA certified. I am excited about this development because this will begin to build our credibility in the medical and institutional markets." He further stated, "The Company is currently working with a number of vendors who have major entree into these markets."
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.
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