Bed, Therapeutic, Ac-Powered, Adjustable Home-Use

How Is LLI Classified?

Bed, Therapeutic, Ac-Powered, Adjustable Home-Use is FDA product code LLI, Class 2, 21 CFR 880.5100.

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 Do the Recalls Say?

The FDA has recorded 19 recalls under this product code since 2003. None was by a company in China. 6 are Class I, the most serious grade.

The root causes the FDA records most often are Device Design (7), Component design/selection (6) and Labeling design (1). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.