Fall Prevention Alarm/Sensor Combination Attached Or Unattached
PJO · Class I — Low Risk (general controls) · General Hospital · 21 CFR 880.2400
Classification
FDA Product Code
PJO
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 880.2400
Review panel
HO
Medical specialty
General Hospital
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.