The Defender Room Air Cleaner ("Defender") is a portable, mechanical air filtration system designed for single use int he home environment. It is configured as a circular unit with a…
The Defender Room Air Cleaner (“Defender”) is a portable, mechanical air filtration system designed for single use int he home environment. It is configured as a circular unit with a protective outer housing, a pleated fiberglass filter that exceeds HEPA filters in both efficiency and particulate size, and an oxygen activated charcoal filter (HEGA) to remove gasses and odors. During operation, air is drawn into the lower assembly, passes through the upper assembly providing a 360-degree flow of air. The unit is equipped with a scent generator powered by a small heating element. Outlet filtered air passes through the scent generator and out from the top of the unit. The Defender is intended to filter indoor air to remove micro-particles as small as 0.1 micron in size. Including dust, pollen, smoke, dust mites allergens, cockroach allergens, bacteria, mold and pet allergens. The Defender is also intended to remove Tobacco smoke and other household odors.
Who Else Makes It
Concentrated in Guangdong (1), Jiangsu (1).
Record
Regulatory record for Defender | Listed by | Health Mor At Home Cbp |
| FDA product code | FRF |
| Device type | Cleaner, Air, Medical Recirculating |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5045 |
| 510(k) | K010616 |
| Record published | 2021-03-11 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.