Tent, Oxygen
Who Makes This Device Type in China?
The one Chinese manufacturer registered for this device type is based in Jiangsu. 1 is a contract manufacturer.
- Farstar (Wuxi) Medical Equipment Co., Ltd. Jiangsu, contract manufacturer
How Is BYL Classified?
Tent, Oxygen is FDA product code BYL, Class 1, 21 CFR 868.5700.
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 2011. None was by a company in China. The root cause the FDA records most often is Nonconforming Material/Component (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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