KTH · Device, Anti-Stammering
Ear, Nose, Throat · 21 CFR 874.5840 · Class 1
Overview
| Product Code | KTH |
|---|---|
| Device Name | Device, Anti-Stammering |
| Regulation | 21 CFR 874.5840 |
| Device Class | Class 1 |
| Review Panel | Ear, Nose, Throat |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K962961 | SUSTAINED PHONATION | Surface Mount Technology, Inc. | Sep 9, 1996 | SESE |
| K942651 | BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS | Casa Futura Technologies | Oct 19, 1995 | SESE |
| K871590 | VOCALTECH VOCAL FEEDBACK DEVICE | Vocaltech C/O Hogan & Hartson | Oct 6, 1987 | SESE |
| K800445 | EDINBURGH MASKER | Foundation For Fluency, Inc. | Mar 12, 1980 | SESE |
Top Applicants
- Casa Futura Technologies — 1 clearance
- Foundation For Fluency, Inc. — 1 clearance
- Surface Mount Technology, Inc. — 1 clearance
- Vocaltech C/O Hogan & Hartson — 1 clearance
