← Product Code [KTH](/submissions/EN/subpart-f%E2%80%94therapeutic-devices/KTH) · K800445

# EDINBURGH MASKER (K800445)

_Foundation For Fluency, Inc. · KTH · Mar 12, 1980 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/KTH/K800445

## Device Facts

- **Applicant:** Foundation For Fluency, Inc.
- **Product Code:** [KTH](/submissions/EN/subpart-f%E2%80%94therapeutic-devices/KTH.md)
- **Decision Date:** Mar 12, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.5840
- **Device Class:** Class 1
- **Review Panel:** Ear, Nose, Throat

## Regulatory Identification

An antistammering device is a device that electronically generates a noise when activated or when it senses the user's speech and that is intended to prevent the user from hearing the sounds of his or her own voice. The device is used to minimize a user's involuntary hesitative or repetitive speech.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/KTH/K800445](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/KTH/K800445)

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