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FDA 510(k)

Tuned Self-Fitting Mobile App

K-Number: K251208 · 2025-09-26

ApplicantTuned , Ltd.
Decision Date2025-09-26
Product CodeSCR
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Tuned Self-Fitting Mobile App is a medical device manufactured by Tuned , Ltd.. It received FDA 510(k) clearance on 2025-09-26 under approval number K251208. The device is classified under product code SCR. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tuned Self-Fitting Mobile App?

Tuned Self-Fitting Mobile App is a medical device that received FDA 510(k) clearance on 2025-09-26. It is manufactured by Tuned , Ltd.. The 510(k) number is K251208.

When was Tuned Self-Fitting Mobile App approved by the FDA?

Tuned Self-Fitting Mobile App received FDA 510(k) clearance on 2025-09-26, under approval number K251208.

What company makes Tuned Self-Fitting Mobile App?

Tuned Self-Fitting Mobile App is manufactured by Tuned , Ltd..

What is the FDA product code for Tuned Self-Fitting Mobile App?

The FDA product code for Tuned Self-Fitting Mobile App is SCR.

Related Clinical Trials

NCT07499310 The Safety and Effectiveness of Q Therapeutic System, Frequency-tuned Electromagnetic Field Treatment in Facilitating the Recovery of Patients With Chronic Stroke. NOT_YET_RECRUITING

Other Devices by Tuned , Ltd.

K223848Intrisound™ Tuned Lumen® 155 Hearing Aids

Related Devices (Code: SCR)

DEN230081Hearing Aid Feature (HAF)Apple, Inc. K243150Nuance Audio Hearing Aid SoftwareLuxottica Group S.P.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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