RGS Mini
RGS mini is a medical air purifier that combines particle filtration with ultraviolet activated photocatalysis. Air passes through a MERV 13 filter and a component containing a titanium…
RGS mini is a medical air purifier that combines particle filtration with ultraviolet activated photocatalysis. Air passes through a MERV 13 filter and a component containing a titanium dioxide coated mesh and ultraviolet lights. The filter captures particles while the photocatalytic stage acts on microorganisms in the treated air.
Ultraviolet C light activates the titanium dioxide coating, which drives the chemical reaction used in the treatment stage. A fan moves air through this filtration and photocatalytic arrangement. The mini model has a specified high fan speed of 500 cubic feet per minute.
Listed Item
The RGS mini is a medical ultraviolet air purifier that is intended for medical purposes. It is used to destroy bacteria in the air by exposure to ultraviolet radiation. The RGS mini have demonstrated the ability to deactivate Staphylococcus Epidermidis, Bacteriophage MS2, and Escherichia Coli in the air of the test chamber in 60 minutes under the following conditions.
Treatment Scope
The device treats air outside the body and is intended for medical air purification. Its ultraviolet and photocatalytic functions operate within the air handling system as part of that process.
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Ajax Medical Equipment Co Ltd | Guangzhou | Guangdong | Manufacturer | 13 |
| Shenzhen Airgle Corporation Limited | Shenzhen | Guangdong | Manufacturer | 4 |
Record
| Listed by | Genesis AIR, Inc., United States |
|---|---|
| FDA product code | FRA |
| Device type | Purifier, Air, Ultraviolet, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6500 |
| Establishment | Manufacturer |
| 510(k) | K222702 |
| Record published | 2023-07-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RGS mini | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Airgle | Airgle Corporation | 10 |
| RGF-BioControls | RGF Environmental Group, Inc | 9 |
| Aerobiotix | Aerobiotix USA | 5 |
| ADS | Guangzhou Ajax Medical Equipment Co Ltd | 5 |
| Molekule Air Mini + | Molekule Group, Inc. | 2 |
| Molekule | Molekule Group, Inc. | 1 |
| The Pyure Company | The Pyure Company Inc | 1 |
| ActivePure Medical Guardian | Activepure Medical LLC | 1 |
| Purgo | Molekule Group, Inc. | 1 |
| Medical Guardian | Aerus Medical, LLC | 1 |
| RGS | Genesis AIR, Inc. | 1 |
| Molekule Air Pro | Molekule Group, Inc. | 1 |
Showing 12 of 13. All products under Purifier, Air, Ultraviolet, Medical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222702 | 2023-06-02 |
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.