Molekule
Molekule Air Pro RX is a medical ultraviolet air purifier. The FDA filing identifies it as a freestanding device, distinguishing its placement from a predicate purifier installed in a…
Molekule Air Pro RX is a medical ultraviolet air purifier. The FDA filing identifies it as a freestanding device, distinguishing its placement from a predicate purifier installed in a ventilation duct.
The submitted device is identified by the exact trade name Molekule Air Pro RX and product code FRA. The filing classifies it as an air purifier and compares it with another medical ultraviolet air purifier, describing the Air Pro RX as a standalone room unit.
Listed Item
The Molekule Air Pro RX 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
Device Form
The filing distinguishes the freestanding Air Pro RX from the Transformair predicate, which is installed in a ventilation duct. This describes the physical configuration of the listed model.
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) | K200500 |
| Record published | 2020-10-14 |
| Record revised | 2023-10-18 (version 5) |
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 |
|---|---|---|
| Air Pro RX | 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 |
| 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.