PJPClass I
Fall Prevention Alarm/sensor Attached Only
General Hospital · 21 CFR 880.2400
This fall-prevention alarm/sensor works only when it is attached to a person. It attaches to a person usually by a clip or belt .
MDR events33All time
Recalls0All time
Registered firms8Currently listed
510(k) clearances0All time
Recent MDR events
33 adverse event reports on file
- BELLE MEDICAL ALERT SYSTEMNov 4, 2024MalfunctionUniversal Medical DataMW5162184
- ALARM SENSOR, HOOK & LOOP ALARM BELT SENSORFeb 2, 2024MalfunctionTidi Products Llc2182318-2024-00004
- DISPOSABLE CHAIR ALARM BELTJan 8, 2024MalfunctionTidi Products Llc2182318-2023-00123
- DISPOSABLE BED SENSOR BELTAug 30, 2023MalfunctionTidi Products Llc2182318-2023-00087
- DISPOSABLE BED SENSOR BELTJul 27, 2023MalfunctionTidi Products Llc2182318-2023-00068
- DISPOSABLE BED SENSOR BELTJul 18, 2023MalfunctionTidi Products Llc2182318-2023-00065
- DISPOSABLE BED SENSOR BELTJul 11, 2023MalfunctionTidi Products Llc2182318-2023-00060
- DISPOSABLE BED SENSOR BELTJul 7, 2023MalfunctionTidi Products Llc2182318-2023-00059
- DISPOSABLE BED SENSOR BELTJul 7, 2023MalfunctionTidi Products Llc2182318-2023-00058
- DISPOSABLE BED SENSOR BELTJun 22, 2023MalfunctionTidi Products Llc2182318-2023-00055
Event type breakdown
Malfunction32
Injury1
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
8 firms currently registered for this product code
Crest Electronics Inc.
DASSEL, MN, US
Stl Electronics Ltd
Kwai Chung, HK
Tidi Products, Llc
NEENAH, WI, US
Posey, S. De R.l. De C.v.
TIJUANA Baja California, MX
Linus Health, Inc.
Boston, MA, US
Posey, S. De R.l. De C.v.
Tijuana Baja California, MX
Posey, S. De R.l. De C.v.
Tijuana Baja California, MX
Us Patientcare Products Llc
Bixby, OK, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.