Saw, Powered, and Accessories

How Is HAB Classified?

Saw, Powered, And Accessories is FDA product code HAB, Class 1, 21 CFR 878.4820.

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 16 recalls under this product code since 2008. None was by a company in China. The root causes the FDA records most often are Labeling Change Control (6), Process control (5) and Device Design (3).

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