Binder, Perineal
Which Manufacturers in China Make This?
2 manufacturers in China hold an FDA registration for this device type, based in Guangdong and Zhejiang.
- Dongguan Supercare Medical Products Co., Ltd. Guangdong, contract manufacturer
- Ningbo MPF Manufacturing Co., Ltd. Zhejiang, contract manufacturer
What Is FDA Product Code FQK?
Binder, Perineal is FDA product code FQK, Class 1, 21 CFR 880.5160.
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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