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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 the device name listed in this FDA 510(k) record. The listed applicant is Tuned , Ltd.. It received FDA 510(k) clearance on 2025-09-26 under 510(k) 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. The listed applicant is Tuned , Ltd.. The 510(k) number is K251208.

When did Tuned Self-Fitting Mobile App receive FDA 510(k) clearance?

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

Who is the listed applicant for Tuned Self-Fitting Mobile App?

The FDA 510(k) record lists Tuned , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07499310The Safety and Effectiveness of Q Therapeutic System, Frequency-tuned Electromagnetic Field Treatment in Facilitating the Recovery of Patients With Chronic Stroke.NOT_YET_RECRUITINGNCT05427734Drivers of Suicide Mobile App StudyCOMPLETEDNCT05499676Helping HAND: Healing Anorexia Nervosa DigitallyCOMPLETEDNCT05557123Mobile App for Improving Adherence of Rivoxaban (RIVOX-AF)COMPLETEDNCT05601583Care Partner-Assisted Diabetes Self-Management Through Linking Continuous Glucose Monitoring With Mobile Health: Improving Outcomes for Older Adults With Mild Cognitive ImpairmentCOMPLETEDNCT06053268Mindfulness Interventions to Improve Health Activation, Coping, and Stress Among Childhood Cancer SurvivorsACTIVE_NOT_RECRUITING

Other records listing Tuned , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223848Intrisound™ Tuned Lumen® 155 Hearing Aids

Related Devices (Code: SCR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261187Hearing Aid FeatureSamsung Electronics Co., Ltd.K254044Hearing assistMeta Platform Technologies, LLCK243150Nuance 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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