Twister, Brace Setting
Who Makes This Device Type in China?
The one Chinese manufacturer registered for this device type is based in Jiangsu.
- GE Medical Systems (China) Co., Ltd. Jiangsu, contract manufacturer
What Is FDA Product Code ITO?
Twister, Brace Setting is FDA product code ITO, Class 1, 21 CFR 890.3410.
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. It is also exempt from most of the quality system regulation.
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