Stretcher, Patient Restraint

What Is It?

Soft restraints to be attached to a backboard or stretcher in order to immobilize the patient in emgency situations.

What Is FDA Product Code NZD?

Stretcher, Patient Restraint is FDA product code NZD, Class 1, 21 CFR 880.6900.

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. It is also exempt from most of the quality system regulation.

What Do the Recalls Say?

The FDA has recorded 2 recalls under this product code since 2016. None was by a company in China. The root cause the FDA records most often is Process control (2).

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