Data / Medical devices / United States / Vibralung, Inc.
Vibralung, Inc.: FDA-registered device maker in Parker, CO, United States, 1 510(k) clearance
Vibralung, Inc. is registered with the FDA (registration 3007858792) in Parker, CO, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 23, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007858792
- Address
- 11990 Meadowood Lane, Parker, CO, United States, 80138
- Owner or operator
- VibraLung, Inc. (10084462)
- Roles
- Manufacturer
- First device listed
- February 24, 2022
- Registered through
- 2026
- Brand names listed
- Vibralung® Acoustical Percussor, Vibralung® Full User Kit/Travel Bag, Vibralung® HHT Hanger, Vibralung® Mask Interface Kit-Adult with Aerosol Delivery System, Vibralung® Mask Interface Kit-Pediatric w/Aerosol Delivery System, Vibralung® Patient Change Kit, Vibralung® Patient Kit, Vibralung® Trach Interface Kit with Aerosol Delivery System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intra-Pulmonary Percussive Vibration (Ipv) Devices | SDT | 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 |
|---|---|---|---|---|---|---|
| May 23, 2014 | K133057 | VIBRALUNG ACOUSTICAL PERCUSSOR | SDT | Substantially Equivalent | Westmed, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 23, 2014. 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.