What Is FDA Product Code ILY?
Lamp, Infrared, Therapeutic Heating is FDA product code ILY, Class 2, 21 CFR 890.5500.
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 20 recalls under this product code since 2006. None was by a company in China. The root causes the FDA records most often are Device Design (7), Process control (4) and No Marketing Application (3).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.