21 CFR 874.5840 — Device, Anti-Stammering
Ear, Nose, Throat (EN) · Part 874 Subpart F—Therapeutic Devices · § 874.5840
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KTH | Device, Anti-Stammering | 1 | 4 |
