BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS
Device Facts
| Record ID | K942651 |
|---|---|
| Device Name | BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS |
| Applicant | Casa Futura Technologies |
| Product Code | KTH · Ear, Nose, Throat |
| Decision Date | Oct 19, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.5840 |
| Device Class | Class 1 |
Regulatory Classification
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.
