System, Environmental Control, Powered

What Is FDA Product Code IQA?

System, Environmental Control, Powered is FDA product code IQA, Class 2, 21 CFR 890.3725.

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.

What Do the Recalls Say?

The FDA has recorded 17 recalls under this product code since 2011. None was by a company in China. The root causes the FDA records most often are Component change control (3), Software Manufacturing/Software Deployment (3) and Software design (2).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.