Unit, Chilling
Which Manufacturers in China Make This?
3 manufacturers in China hold an FDA registration for this device type, based in Guangdong and Henan.
- Dongguan Quanding Medical Supplies Co., Ltd. Guangdong, contract manufacturer
- Linjiang (Holdings) Limited Henan
- Shenzhen City U-Lucky Sporting Goods Co., Ltd. Guangdong, contract manufacturer
How Is IMF Classified?
Unit, Chilling is FDA product code IMF, Class 1, 21 CFR 890.5940.
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.
What Has Gone Wrong With It?
The FDA has recorded 1 recall under this product code since 2018. None was by a company in China. The root cause the FDA records most often is Process change control (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
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Record