Product code
PJO: Fall prevention alarm/sensor combination attached or unattached
FDA product code · Class I · General Hospital
Key facts
| Product code | PJO |
|---|---|
| Device | Fall prevention alarm/sensor combination attached or unattached |
| Device class | Class I |
| Regulation number | 880.2400 |
| Review panel | General Hospital |
| Medical specialty | General Hospital |
| Submission type | 510(K) Exempt |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| 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. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 100–999 MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database