Bariatric Bed

What Is This Device?

A bed intended for obese patients weighing 500 pounds and above. Beds can expand from 38 to 60 inches in width.

How Is OSI Classified?

Bariatric Bed is FDA product code OSI, 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 Has Gone Wrong With It?

The FDA has recorded 4 recalls under this product code since 2012. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (2), Device Design (1) and Release of Material/Component prior to receiving test results (1).

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