Molekule Air Mini +
The Molekule Air Mini and Air Mini+ purifiers capture airborne particles and use ultraviolet-activated filtration to destroy bacteria and viruses trapped on the filter. They are…
The Molekule Air Mini and Air Mini+ purifiers capture airborne particles and use ultraviolet-activated filtration to destroy bacteria and viruses trapped on the filter. They are freestanding devices for medical facilities and homes. For the Air Mini+, the specified purification indication requires manual operation at fan speed three or higher.
A fan draws air through bottom vents, across a catalytic filter and out through top vents. UV-A light activates the filter, generating hydroxyl radicals that oxidize captured microorganisms. A touch control operates power and fan speed; a connected Android or iOS application provides another control interface.
Listed Item
The Molekule Air Mini air purifier is a device intended for medical purposes that is used to destroy bacteria and viruses in the air by exposure to ultraviolet radiation
Air Mini+ Controls
The Air Mini+ adds a particulate sensor, an indicator and an automatic mode that adjusts fan speed to measured particle levels. This automatic mode is distinct from the manual-speed condition specified for its medical purification indication.
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 | Molekule Group, Inc., United States |
|---|---|
| FDA product code | FRA |
| Device type | Purifier, Air, Ultraviolet, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6500 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K202339 |
| Record published | 2021-02-25 |
| Record revised | 2023-10-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MN1P-US | In distribution | |
| MN1B-US | 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 | Molekule Group, Inc. | 1 |
| The Pyure Company | The Pyure Company Inc | 1 |
| ActivePure Medical Guardian | Activepure Medical LLC | 1 |
| Purgo | Molekule Group, Inc. | 1 |
| RGS mini | Genesis AIR, 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 |
|---|---|
| K211194 | 2021-08-20 |
| K202339 | 2021-02-23 |
| K200500 | 2020-04-15 |
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.