What Is This Device?
The uterine electromyographic monitor is intended to pick up uterine emg signals from surface electrodes placed on the maternal abdomen. It produces a uterine activity tracing and monitors women in labor at term gestation with a singleton pregnancy.
How Is OSP Classified?
Uterine Electromyographic Monitor is FDA product code OSP, Class 2, 21 CFR 884.2720.
How Does It Reach the US Market?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.
What Has Gone Wrong With It?
The FDA has recorded 3 recalls under this product code since 2017. None was by a company in China. The root causes the FDA records most often are Device Design (2) and Nonconforming Material/Component (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.