Data / Medical devices / United States / ActivePure Manufacturing LLC
ActivePure Manufacturing LLC: FDA-registered device maker in Bristol, VA, United States, 1 510(k) clearance
ActivePure Manufacturing LLC is registered with the FDA (registration 3003547411) in Bristol, VA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 17, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003547411
- Address
- 1300 Valley Dr, Bristol, VA, United States, 24201
- Owner or operator
- ActivePure Medical LLC (10075792)
- Roles
- Manufacturer
- First device listed
- June 26, 2020
- Registered through
- 2026
- Brand names listed
- ActivePure Medical Guardian, Aerus Medical Guardian
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Purifier, Air, Ultraviolet, Medical | FRA | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 17, 2020 | K201220 | Aerus Medical Guardian,model F170A | FRA | Substantially Equivalent | Aerus Medical, LLC | accessdata.fda.gov |
Compare with other makers
Updated June 17, 2020. 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.