K-number	K251208
Device name	Tuned Self-Fitting Mobile App
Applicant	Tuned , Ltd.
Product code	SCR
Device class	Class II
Decision date	Sep 26, 2025
Decision	Substantially Equivalent
Regulation	874.3335

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Tuned Self-Fitting Mobile App

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