The FilterQueen® Defender® Room Air Cleaner is recognized as a Class II medical device by the Food and Drug Administration (FDA).
The FDA has recognized three classes of medical devices based on the level of control necessary to assure the safety and effectiveness of the device. Class II medical devices are subject to special controls and standards, while providing safety to users of the products.
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, the Defender® was found to have efficiency ratings better than HEPA (High Efficiency Particulate Air), the industry standard.
The Defender® is manufactured using Good Manufacturing Practice (GMP) requirements, which are enforced in the U.S. by the FDA. GMP requirements outline the aspects of production and testing that can impact the quality of a product.
Health-Mor is dedicated to delivering safe and dependable products that are the best in its industry. Consequently, the Defender® Room Air Cleaner is both ISO 9001 and ISO 13485 Certified. ISO 9001 is an internationally recognized Quality Management System, with the focus on increasing customer satisfaction. ISO 13485 is specific to the design and manufacture of medical devices, with the focus on meeting regulatory requirements.
regarding bacterial filtration efficiency tests, airborne molecular contamination tests, filter efficiency tests and clean air delivery rates is available from Health-Mor.