Data / Medical devices / United States / Gelb Practice
Gelb Practice: FDA-registered device maker in Dix Hills, NY, United States, 1 510(k) clearance
Gelb Practice is registered with the FDA (registration 3030914478) in Dix Hills, NY, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 14, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030914478
- Address
- 52 Woodedge drive, Dix Hills, NY, United States, 11746
- Owner or operator
- Gelb Practice (10090614)
- Roles
- Specification developer
- First device listed
- April 18, 2024
- Registered through
- 2026
- Brand names listed
- airVataTM
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Anti-Snoring | LRK | 2 | Specification developer | accessdata.fda.gov |
| Device, Jaw Repositioning | LQZ | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| February 14, 2024 | K240427 | airVata | LRK | Substantially Equivalent | Gelb Practice Solutions, Inc. | accessdata.fda.gov |
Compare with other makers
Updated February 14, 2024. 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.