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Tuned , Ltd.

FDA 510(k) & PMA Approved Devices — 2 products

Total Devices2
Categories2
Latest FDA decision2025-09-26
TypeNumberDevice NameCodeDateActions
510(k) K251208 Tuned Self-Fitting Mobile AppSCR2025-09-26 View
510(k) K223848 Intrisound™ Tuned Lumen® 155 Hearing AidsQUH2023-09-08 View

Related Clinical Trials

NCT02603640" Virtual Brain "-Based Interpretation of Electrophysiological Signals in EpilepsyCOMPLETEDNCT07095920RESPARK - Brain Q for Chronic StrokeRECRUITINGNCT07499310The Safety and Effectiveness of Q Therapeutic System, Frequency-tuned Electromagnetic Field Treatment in Facilitating the Recovery of Patients With Chronic Stroke.NOT_YET_RECRUITING
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