Devices, Breath Trapping, Alcohol

How Is DJZ Classified?

Devices, Breath Trapping, Alcohol is FDA product code DJZ, Class 1, 21 CFR 862.3050.

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 Has Gone Wrong With It?

The FDA has recorded 3 recalls under this product code since 2005. None was by a company in China. The root causes the FDA records most often are Labeling False and Misleading (1) and PMA (1).

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