510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PJOClass I

Fall Prevention Alarm/Sensor Combination Attached Or Unattached

21 CFR 880.2400 / General Hospital
FDA source (opens on fda.gov)

PJO is the FDA product code for Fall Prevention Alarm/Sensor Combination Attached Or Unattached, a class I device type, regulated under 21 CFR 880.2400. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
PJO
Device name
Fall Prevention Alarm/Sensor Combination Attached Or Unattached
FDA 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.
Regulation
21 CFR 880.2400
Device class
Class I
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code