Data / Medical devices / Israel / Tuned Ltd
Tuned Ltd: FDA-registered device maker in Gan Yoshiya Central, Israel, 2 510(k) clearances
Tuned Ltd is registered with the FDA (registration 3023339161) in Gan Yoshiya Central, Israel. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 26, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3023339161
- Address
- Harimon, Gan Yoshiya Central, Israel, 38850
- Owner or operator
- Tuned LTD (10085651)
- Roles
- Manufacturer
- First device listed
- October 18, 2023
- Registered through
- 2026
- Brand names listed
- JVC EH-Z2000, Tuned Hearing Mobile App
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Air-Conduction Hearing Aid Software | SCR | 2 | Manufacturer | accessdata.fda.gov |
| Self-Fitting Air-Conduction Hearing Aid, Over The Counter | QUH | 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 |
|---|---|---|---|---|---|---|
| September 26, 2025 | K251208 | Tuned Self-Fitting Mobile App | SCR | Substantially Equivalent | Tuned , Ltd. | accessdata.fda.gov |
| September 8, 2023 | K223848 | Intrisound Tuned Lumen® 155 Hearing Aids | QUH | Substantially Equivalent | Tuned , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Self-Fitting Air-Conduction Hearing Aid, Over The Counter
- All makers of Air-Conduction Hearing Aid Software
Updated September 26, 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.