Molekule Air Mini + Retail
The Molekule Air Mini+ is a freestanding air purifier for medical facilities and home use. A fan draws air through a catalytic filter illuminated by ultraviolet A light, then releases the…
The Molekule Air Mini+ is a freestanding air purifier for medical facilities and home use. A fan draws air through a catalytic filter illuminated by ultraviolet A light, then releases the filtered air through vents at the top of the unit.
The UV-A light initiates a reaction at the filter that produces hydroxyl radicals, which react with captured bacteria and viruses. The stated medical use requires manual operation at fan speed 3 or higher.
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
Controls and Sensing
A touch button controls power and fan speed, with LED indicators showing device status. WLAN allows control from the Molekule mobile app. The Mini+ also includes a particulate sensor and indicator, with an automatic mode that adjusts fan speed in response to particulate levels.
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 Retail | 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 |
| RGS mini | Genesis AIR, Inc. | 1 |
| Medical Guardian | Aerus Medical, LLC | 1 |
| RGS | Genesis AIR, 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.