Shoes, Operating-Room
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are concentrated in Hubei, Anhui and Jiangsu, and 2 other provinces: 6 hold an FDA registration. 1 is a contract manufacturer.
- Hangzhou Zhongzhi Industry Co., Ltd. Zhejiang
- Hospital & Homecare IMP. & EXP. Co., Ltd. Jiangsu, contract manufacturer
- Planet (Anhui) International Co., Ltd. Anhui
- Planet(Shanghai) International Co., Ltd. Shanghai
- Xianning Full Guard Medical Products Co., Ltd. Hubei
- Xiantao Rayxin Medical Products Co., Ltd. Hubei, contract manufacturer
What Is FDA Product Code FXW?
Shoes, Operating-Room is FDA product code FXW, Class 1, 21 CFR 878.4040.
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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