Data / Medical devices / Purifier, Air, Ultraviolet, Medical
Purifier, Air, Ultraviolet, Medical (FRA): 12 FDA-registered makers in 3 countries
12 establishments in 3 countries are registered with the FDA to make Purifier, Air, Ultraviolet, Medical (product code FRA, Class 2, 21 CFR 880.6500). 12 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 36 510(k) clearances under this code, the latest on September 15, 2025, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- FRA
- Device class
- 2
- Regulation
- 880.6500
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| China | 2 |
| Singapore | 1 |
Makers of Purifier, Air, Ultraviolet, Medical
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Molekule Group, Inc. | Lakeland, FL, United States | Complaint file establishment, Specification developer | 3 | August 20, 2021 | 0 | 0 | 0 | api.fda.gov |
| Healkee Medical Pte. Ltd. | Singapore North West, Singapore | Specification developer | 2 | May 23, 2024 | 0 | 0 | 0 | api.fda.gov |
| Aerobiotix Usa | Miamisburg, OH, United States | Manufacturer | 1 | January 21, 2021 | 0 | 0 | 0 | api.fda.gov |
| Airgle Corporation | Holbrook, NY, United States | Complaint file establishment, Specification developer | 1 | February 16, 2024 | 0 | 0 | 0 | api.fda.gov |
| Applied Photonix LLC | Tampa, FL, United States | Manufacturer | 1 | August 1, 2024 | 0 | 0 | 0 | api.fda.gov |
| ActivePure Manufacturing LLC | Bristol, VA, United States | Manufacturer | 1 | June 17, 2020 | 0 | 0 | 0 | api.fda.gov |
| Airocide Systems | Neptune Beach, FL, United States | Manufacturer | 1 | February 24, 2006 | 0 | 0 | 0 | api.fda.gov |
| Genesis Air, Inc. | Lubbock, TX, United States | Manufacturer | 1 | June 2, 2023 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou Ajax Medical Equipment Co Ltd | Guangzhou Guangdong, China | Manufacturer | 1 | June 11, 2021 | 0 | 0 | 0 | api.fda.gov |
| RGF Environmental Group, Inc | Riviera Beach, FL, United States | Manufacturer | 1 | December 1, 1997 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Airgle Corporation Limited | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 1 | February 16, 2024 | 0 | 0 | 0 | api.fda.gov |
| The Pyure Company Inc | Boynton Beach, FL, United States | Manufacturer | 1 | December 19, 2014 | 0 | 0 | 0 | api.fda.gov |
Updated September 15, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.