Class II Medical Device

Defender Room Air Cleaner Qualified
as Medical Device by FDA
HMI Industries Inc., manufacturer of the FILTERQUEEN brand of indoor air filtration appliances has been cleared by the FDA (Food and Drug Administration) to market the Defender Room Air Cleaner as a Class II medical device.

The Defender was found to have efficiency ratings better than HEPA (High Efficiency Particulate Air), the industry standard.

"The Defender is a medical device designed to remove airborne particles and allergens such as dust, smoke, pollen, mold spores, animal dander, dust mites, and harmful fibers that may lead to allergic reactions," said John A. Pryor, President and COO of HMI Industries. "HMI's initiative from day one has been to provide our customers with the highest quality indoor air filtration products in the industry, and we're proud to have our success validated by the FDA, " he continued.

The decision by the FDA allows HMI to commercially market the Defender Room Air Cleaner for medical uses.

The Defender will be manufactured utilizing the FDA's Good Manufacturing Practice Requirements (GMP), that govern methods used in design, parts purchasing, manufacture, packaging, labeling, storing, installation, and service of product.

Test data regarding bacterial filtration efficiency tests, airborne molecular contamination tests, filter efficiency tests, and clean air delivery rates is available from HMI Industries.

HMI Industries Inc. is a Cleveland, Ohio based, worldwide, direct selling company engaged in the manufacture and sale of high filtration portable surface cleaners, central vacuum cleaning systems, and portable room air cleaners under the FILTERQUEEN brand name.

Source: The Cleveland Plain Dealer - Thursday, November 30, 2000