FDA product code PJP: Fall Prevention Alarm/Sensor Attached Only

PJP is the FDA product code for fall prevention alarm/sensor attached only. It is a Class I device, regulated under 21 CFR 880.2400 and reviewed by the General Hospital panel. Devices under PJP reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.

Definition

This fall-prevention alarm/sensor works only when it is attached to a person. It attaches to a person usually by a clip or belt .

Classification

FieldValue
Device nameFall Prevention Alarm/Sensor Attached Only
Device classClass I
Regulation21 CFR 880.2400
Review panelHO — General Hospital
Medical specialtyGeneral Hospital
Premarket route510(k) exempt

Recalls for PJP devices

openFDA lists no recalls for product code PJP.

Frequently asked questions

What is FDA product code PJP?

PJP is the FDA product code for fall prevention alarm/sensor attached only. It is a Class I device, regulated under 21 CFR 880.2400 and reviewed by the General Hospital panel.

What device class is PJP?

Class I, regulation 21 CFR 880.2400. Typical premarket route: 510(k) exempt.

Next steps

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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