Fall Prevention Alarm/Sensor Combination Attached or Unattached

What Is This Device?

The fall-prevention alarm/sensor is a combination device that can attach to a person usually by a clip or belt OR it can be used unattached to the person, where the person sits upon it.

How Is PJO Classified?

Fall Prevention Alarm/Sensor Combination Attached Or Unattached is FDA product code PJO, Class 1, 21 CFR 880.2400.

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.