Tuned, Ltd.
IsraelFDA 510(k) applicant, unverified FDA
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Tuned, Ltd. makes
Tuned, Ltd. manufactures the Intrisound™ Tuned Lumen® 155 hearing aids, which are designed for customizable auditory solutions, and the Tuned Self-Fitting Mobile App, a software tool for personalized hearing adjustments.
These devices fall under FDA Class II regulation and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Intrisound™ Tuned Lumen® 155 Hearing Aids Ref K223848
510(k) 510(k)Tuned Self-Fitting Mobile App Ref K251208
510(k) 510(k)
FDA establishments
- Tuned Ltd Gan Yoshiya Central · IL FEI 3023339161
Frequently asked questions
How many devices does Tuned, Ltd. have in the registry?
The registry currently lists 2 devices for Tuned, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tuned, Ltd.'s devices?
Among its 2 most recently registered devices, Tuned, Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Tuned, Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Tuned, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Tuned, Ltd. in the registry?
The most recently registered devices listed for Tuned, Ltd. include Intrisound™ Tuned Lumen® 155 Hearing Aids and Tuned Self-Fitting Mobile App.
Which FDA establishments are linked to Tuned, Ltd.?
1 FDA establishment is linked to Tuned, Ltd. in the registry; they are listed on the company page.