PJO — Fall Prevention Alarm/Sensor Combination Attached Or Unattached Class I
FDA product code PJO covers "Fall Prevention Alarm/Sensor Combination Attached Or Unattached", a Class I medical device regulated under 21 CFR 880.2400. Submissions are reviewed by the General Hospital panel.
Classification Details
- Product Code
- PJO
- Device Class
- Class I
- Regulation Number
- 880.2400
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- 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.