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…
Device, Anti-Stammering
Who Makes This Device Type in China?
One manufacturer in China holds an FDA registration for this device type, based in Fujian. All of them are contract manufacturers, able to build to a buyer’s own specification.
- Xiamen Newsound Technology Co., Ltd. Fujian, contract manufacturer
What Is FDA Product Code KTH?
Device, Anti-Stammering is FDA product code KTH, Class 1, 21 CFR 874.5840.
How Does It Reach the US Market?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.
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