Powered Tongue Scraper
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are concentrated in Guangdong, Guangxi and Hong Kong, and 1 other province: 4 hold an FDA registration.
- Nanning Sixtant Biotechnology Co., Ltd. Guangxi
- Qibei Technology Co., Limited Hong Kong
- Qingdao S&R Industry AND Trade Co Ltd Shandong
- Shenzhen Ainengke Electronics Co., Ltd. Guangdong
What Is It?
The device is intended to remove debris from the top surface of the tongue as a supplement to normal daily oral hygiene care.
How Is QIA Classified?
Powered Tongue Scraper is FDA product code QIA, Class 1, 21 CFR 872.6865.
What Does It Take to Sell It in the United States?
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.
Name
Record