Joint, Hip, External Limb Component
Who Makes This Device Type in China?
4 manufacturers in China hold an FDA registration for this device type, concentrated in Beijing, Shandong and Shanghai, and 1 other province. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.
- Baoji Shengtaike Industry & Trade Co., Ltd. Shanxi, contract manufacturer
- Himile Mechanical Manufacturing (Shandong) Co., Ltd. Shandong, contract manufacturer
- Huae Trade Technology Co., Ltd. Beijing, contract manufacturer
- Shanghai Wilpower Industrial Co., Ltd. Shanghai
How Is ISL Classified?
Joint, Hip, External Limb Component is FDA product code ISL, Class 1, 21 CFR 890.3420.
What Does It Take to Sell It in the United States?
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.
What Do the Recalls Say?
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 Employee error (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.