Airsonett AIR-4
Airsonett AIR-4 is a mobile air cleaner for home medical use that removes airborne particles near the breathing zone. It draws room air through a HEPA filter and supplies slightly cooled…
Airsonett AIR-4 is a mobile air cleaner for home medical use that removes airborne particles near the breathing zone. It draws room air through a HEPA filter and supplies slightly cooled air through an adjustable overhead nozzle.
The cooler filtered air descends slowly in a low-turbulence flow, counteracting rising body-warmed air. A separate outlet releases warm air from the temperature-control pathway.
Listed Item
Airsonett is based on the Temperature controlled Laminar Airflow (TLA) technology. The air from the room enters the Airsonett and passes a filter that captures allergens and other particles. The filtered air is cooled to slightly below the ambient room temperature and is supplied with a low velocity from the air supply nozzle. Since the filtered air is slightly cooler, and therefore heavier than the surrounding air, the filtered air will descend slowly from the air supply nozzle by means of gravity in a laminar manner (non-turbulent). This descending colder air counteracts the body convection, displaces the allergen load in the breathing zone and thus dramatically reduces the level of inhalant allergens for the patient all through the night.
Controls and Placement
The nozzle height can be adjusted by combining or removing sections of its guidance arm. A microprocessor supervises temperatures, thermoelectric modules and fan operation and tracks total operating time and time since filter replacement.
Who Else Makes It
Concentrated in Guangdong (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Helen of Troy Macao Limited | Macau | Guangdong | Private-label distributor | 11 |
| Suzhou Beiang Smart Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Airsonett AB, Sweden |
|---|---|
| FDA product code | FRF |
| Device type | Cleaner, Air, Medical Recirculating |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5045 |
| Establishment | Manufacturer |
| 510(k) | K130702 |
| Record published | 2023-02-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hepa-Care® | Abatement Technologies Limited | 27 |
| RGF-BioControls | RGF Environmental Group, Inc | 9 |
| TRI-Kleen | TRI-DIM Filter Corporation | 4 |
| Novaerus | Novaerus (Ireland) Limited | 2 |
| SU-Veid | Angie Technologies Ltd | 1 |
| Airsonett AIR-4 A-1100 | Airsonett AB | 1 |
| Defender | Health Mor At Home Cbp | 1 |
| Wellair | Novaerus (Ireland) Limited | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K130702 | 2013-07-23 |
| K081062 | 2008-11-07 |
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.