Device, Anti-Stammering
The Anti-Stammering Device is a therapeutic device used to reduce or manage stuttering and speech dysfluency, typically by providing auditory or other sensory feedback to the user during speech. It is classified as FDA Class 1, the lowest risk designation, subject to general controls only and exempt from premarket notification requirements. The product code is KTH, regulated under 21 CFR 874.5840, within the Ear, Nose, Throat medical specialty. No special flags apply to this device.
Research product code KTH in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- KTH
- Device Class
- FDA class 1
- Regulation Number
- 874.5840
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K962961 | SUSTAINED PHONATION | Sep 09, 1996 | Substantially Equivalent | Surface Mount Technology, Inc. |
| K942651 | BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS | Oct 19, 1995 | Substantially Equivalent | Casa Futura Technologies |
| K871590 | VOCALTECH VOCAL FEEDBACK DEVICE | Oct 06, 1987 | Substantially Equivalent | Vocaltech C/O Hogan & Hartson |
| K800445 | EDINBURGH MASKER | Mar 12, 1980 | Substantially Equivalent | Foundation For Fluency, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.