Speak FOR Less
An antistammering device intended to help individuals who stutter improve their level of fluency. The device modifies how users hear their own voice, supporting smoother and more controlled…
An antistammering device intended to help individuals who stutter improve their level of fluency. The device modifies how users hear their own voice, supporting smoother and more controlled speech patterns by using Delayed Auditory Feedback (DAF) technology with a 70-millisecond time delay.
Who Else Makes It
Registered in Fujian. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xiamen Newsound Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 7 |
Record
| Listed by | Speak FOR Less Ltd |
|---|---|
| FDA product code | KTH |
| Device type | Device, Anti-Stammering |
| Device class | Class 1 |
| Regulation | 21 CFR 874.5840 |
| Premarket notification | Exempt |
| Record published | 2025-01-31 |
| Record revised | 2025-06-09 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
| Packaging | Pack of 12, pack of 20, pack of 50, pack of 100, pack of 8, pack of 15 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FP-A01 | In distribution |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.