Chair, Posture, for Cardiac and Pulmonary Treatment

How Is BYN Classified?

Chair, Posture, For Cardiac And Pulmonary Treatment is FDA product code BYN, Class 1, 21 CFR 868.5365.

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.