Head Halter, Traction
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are concentrated in Guangdong, Zhejiang and Fujian, and 2 other provinces: 10 hold an FDA registration. 3 are contract manufacturers.
- Amis (Xiamen) Cultural Creativity Co., Ltd. Fujian
- Cixi Cijia Handicraft Co., Ltd. Zhejiang, contract manufacturer
- Dongguan Redthera Technology Co., Ltd. Guangdong
- Good Horse Toys AND Gifts Co., Ltd. Guangdong, contract manufacturer
- Hebei Leamai Medical Instrument Co., Ltd. Hebei
- Ningbo Alps Medical Technology Co., Ltd. Zhejiang
- Ningbo Castle Medical Import & Export Co., Ltd. Zhejiang, contract manufacturer
- Ningbo MDC Import & Export Co., Ltd. Shanghai
- Xiamen Longstar Medical Equipment Co., Ltd. Fujian
- Zhongshan Chukuang Textile Co., Ltd. Guangdong, contract manufacturer
What Is FDA Product Code IRS?
Head Halter, Traction is FDA product code IRS, Class 1, 21 CFR 890.5925.
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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