Data / Medical devices / United States / Avation Medical
Avation Medical: FDA-registered device maker in Valencia, CA, United States, 1 510(k) clearance
Avation Medical is registered with the FDA (registration 3027578962) in Valencia, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 3, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027578962
- Address
- 27451 Tourney Rd Ste 100, Valencia, CA, United States, 91355
- Owner or operator
- Avation Medical (10088188)
- Roles
- Manufacturer
- First device listed
- June 7, 2023
- Registered through
- 2026
- Brand names listed
- Vivally System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence | NAM | 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 |
|---|---|---|---|---|---|---|
| April 3, 2023 | K220454 | Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application | NAM | Substantially Equivalent | Avation Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 3, 2023. 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.