Wellair
Medical Recirculating Air Cleaner, free standing, AC powered. The device is a room recirculating air cleaner. The system is used for filtering out and inactivating airborne particles from…
Medical Recirculating Air Cleaner, free standing, AC powered. The device is a room recirculating air cleaner. The system is used for filtering out and inactivating airborne particles from the air for medical purposes. Additional trade names: NV1050 and Defend 1050
2manufacturers in China registered for this device type
1catalogue number
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 | Novaerus (Ireland) Limited |
|---|---|
| FDA product code | FRF |
| Device type | Cleaner, Air, Medical Recirculating |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5045 |
| 510(k) | K200321 |
| Record published | 2026-06-05 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Pro XL | 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 | Airsonett AB | 1 |
| Airsonett AIR-4 A-1100 | Airsonett AB | 1 |
| Defender | Health Mor At Home Cbp | 1 |
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.