Powered Stairway Chair Lift

What Is This Device?

A powered patient stairway chair lift (Stair Machine) is a motorized lift equipped with a seat and permanently mounted in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by moving a person up and down a stairway

What Is FDA Product Code PCD?

Powered Stairway Chair Lift is FDA product code PCD, Class 2, 21 CFR 890.5150.

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 3 recalls under this product code since 2016. None was by a company in China. The root causes the FDA records most often are Component design/selection (2) and Component change control (1).

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