FDA product code PJO: Fall Prevention Alarm/Sensor Combination Attached Or Unattached
PJO is the FDA product code for fall prevention alarm/sensor combination attached or unattached. It is a Class I device, regulated under 21 CFR 880.2400 and reviewed by the General Hospital panel. Devices under PJO reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
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.
Classification
| Field | Value |
|---|---|
| Device name | Fall Prevention Alarm/Sensor Combination Attached Or Unattached |
| Device class | Class I |
| Regulation | 21 CFR 880.2400 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Recalls for PJO devices
openFDA lists no recalls for product code PJO.
Frequently asked questions
What is FDA product code PJO?
PJO is the FDA product code for fall prevention alarm/sensor combination attached or unattached. It is a Class I device, regulated under 21 CFR 880.2400 and reviewed by the General Hospital panel.
What device class is PJO?
Class I, regulation 21 CFR 880.2400. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PJO
- Run a recall and safety report across every PJO manufacturer
- Watch product code PJO for new clearances and recalls
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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