Panels › General Hospital › Product code KMI · Class 1
Monitor, Bed Patient
Regulation 880.2400
0510(k)s in 12 months (31 all time)
0recalls in 12 months (32 all time)
5recalls that name a 510(k)
Top companies in KMI
| Company | 510(k)s | Recalls |
|---|---|---|
| Stanley Security Solutions Inc | 0 | 19 |
| General Electric Medical Systems Information Technology | 0 | 4 |
| Fsm Corp. | 2 | 0 |
| Intel-Ge Care Innovations, LLC | 1 | 1 |
| Medway | 2 | 0 |
| RF Technologies, Inc. | 0 | 2 |
| Tactilitics, Inc. | 2 | 0 |
| Aframe Digital, Inc. | 1 | 0 |
| Alertcare | 1 | 0 |
| Alertronics, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 14, 2020 | Hill-Rom Inc. NaviCare Patient Safety Software Versions 3.5.400-3.9.300.
The NaviCare Patient Safety (Patient Safety) Software is compatible with the following beds:
1. VersaCare
Revision A-J with upgrade kit
Terminated |
KMI | None listed |
| Oct 11, 2018 | Stanley Security Solutions Inc M200 Fall Monitoring System Terminated |
KMI | None listed |
| Mar 3, 2015 | Richard Wolf Medical Instruments Corp. The I-Cart is used to store, transport, and power video equipment used in medical procedures. Terminated |
KMI | None listed |
| Aug 26, 2014 | Curbell Medical, Inc. CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor, MODEL # CSM-BC400; --- COMMON/USUAL NAME: Bed Patient Monitor; CLASSIFICATION NAME: Bed Patient Monitor --- Monitor is connect Terminated |
KMI | None listed |
| Jun 26, 2013 | RF Technologies, Inc. Code Alert Advanced 4-Way Care Solution, CA520 System,
PN 9600-1600, RF Technologies. This product is used to alert caregivers when a patient at risk for falls is leaving a bed or chair. Terminated |
KMI | None listed |
| Feb 23, 2013 | Intel-GE Care Innovations LLC QuietCare-Networked product, Facility Server/model: QC101601;
The QuietCare system is intended to detect and analyze residents' movements. Terminated |
KMI | None listed |
| Sep 28, 2012 | Stanley Security Solutions, Inc. Tabs Professional Voice + Monitor, with wire bracket, Model 25223. Stanley Security Solutions, Inc., Lincoln, NE.
Designed to help reduce the risk of falls by alerting caregivers when a resident is Terminated |
KMI | None listed |
| Sep 28, 2012 | Stanley Security Solutions, Inc. Tabs Professional Voice + Monitor, includes one wall bracket, Model 25222. Stanley Security Solutions, Inc., Lincoln, NE.
Designed to help reduce the risk of falls by alerting caregivers when a resi Terminated |
KMI | None listed |
| Sep 28, 2012 | Stanley Security Solutions, Inc. Tabs Professional Monitor, without pull cord or wall bracket, Model 25025. Stanley Security Solutions, Inc., Lincoln, NE.
Designed to help reduce the risk of falls by alerting caregivers when a resi Terminated |
KMI | None listed |
| Sep 28, 2012 | Stanley Security Solutions, Inc. Tabs Professional Monitor, without wall bracket, Model 25023. Stanley Security Solutions, Inc., Lincoln, NE.
Designed to help reduce the risk of falls by alerting caregivers when a resident is leavi Terminated |
KMI | None listed |
| Sep 28, 2012 | Stanley Security Solutions, Inc. Tabs Professional Monitor, includes one wall bracket, Model 25022. Stanley Security Solutions, Inc., Lincoln, NE.
Designed to help reduce the risk of falls by alerting caregivers when a resident is Terminated |
KMI | None listed |
| Apr 28, 2012 | Stanley Security Solutions, Inc. Micro-Tech Informer Plus Silver Monitor, Model 81830. The firm name on the label is Stanley Security Solutions, Inc., Lincoln, NE.
Product Usage:
The system is a bed exit system designed to indicate Terminated |
KMI | None listed |
| Apr 27, 2012 | Stanley Security Solutions, Inc. UMP Personal Sentry Deluxe Pull String Monitor, Model #91650.
The firm on the label is Universal Medical Products, Lincoln, NE.
Designed to sound an alarm when a patient exceeds his or her safe ra Terminated |
KMI | None listed |
| Mar 31, 2011 | Stanley Security Solutions, Inc. Stanley Bed-Check 90-Day LT Bed Sensormat, With 8 Ft. Cord, Model 74011, 5 mats per inner box, 5 inner boxes per overpack box (total 25 units). The firm name on the box is Stanley, 1-800-523-7956. T Terminated |
KMI | None listed |
| Mar 31, 2011 | Stanley Security Solutions, Inc. Stanley Bed-Check 30-Day IT Bed Sensormat, With 8 Ft. Cord, Model 74010, 10 mats per inner box, 5 inner boxes per overpack box (total 50 units). The firm name on the box is Stanley, 1-800-523-7956. Terminated |
KMI | None listed |
| Mar 31, 2011 | Stanley Security Solutions, Inc. Stanley Bed-Check 90-Day LT Bed Sensormat, With 5.5 Ft. Cord, Model 74001, 5 mats per inner box, 5 inner boxes per overpack box (total 25 units). The firm name on the box is Stanley, 1-800-523-7956. Terminated |
KMI | None listed |
| Mar 31, 2011 | Stanley Security Solutions, Inc. Stanley Bed-Check 30-Day IT Bed Sensormat, With 5.5 Ft. Cord, Model 74000, 10 mats per inner box, 5 inner boxes per overpack box (total 50 units). The firm name on the box is Stanley, 1-800-523-7956. Terminated |
KMI | None listed |
| Mar 31, 2011 | Stanley Security Solutions, Inc. Stanley Bed-Check 30-Day IT Chair Sensormat, With 8 Ft. Cord, Model 73010, 10 mats per inner box, 5 inner boxes per overpack box (total 50 units). The firm name on the box is Stanley, 1-800-523-7956. Terminated |
KMI | None listed |
| Mar 31, 2011 | Stanley Security Solutions, Inc. Stanley Bed-Check 90-Day LT Chair Sensormat, With 4 Ft. Cord, Model 73001, 5 mats per inner box, 5 inner boxes per overpack box (total 25 units). The firm name on the box is Stanley, 1-800-523-7956. Terminated |
KMI | None listed |
| Mar 31, 2011 | Stanley Security Solutions, Inc. Stanley Bed-Check 30-Day IT Chair Sensormat, With 4 Ft. Cord, Model 73000, 10 mats per inner box, 5 inner boxes per overpack box (total 50 units). The firm name on the box is Stanley, 1-800-523-7956. Terminated |
KMI | None listed |
| Jul 1, 2010 | Stanley Security Solutions, Inc. Tabs Professional Monitor with Wire Bracket and Push Button Reset, Model 25223, Stanley Senior Technologies, Lincoln, NE. Terminated |
KMI | K873806 |
| Jul 1, 2010 | Stanley Security Solutions, Inc. Tabs Professional Monitor Without Pull Cord or wall bracket, Model 25025, Stanley Senior Technologies, Lincoln, NE. Terminated |
KMI | K873806 |
| Jul 1, 2010 | Stanley Security Solutions, Inc. Tabs Professional Monitor Without Wall Bracket, Model 25023. Stanley Senior Technologies, Lincoln, NE. Terminated |
KMI | K873806 |
| Jul 1, 2010 | Stanley Security Solutions, Inc. Tabs Professional Monitor, includes one wall bracket, Model 25022. Stanley Senior Technologies, Lincoln, NE. Terminated |
KMI | K873806 |
| Apr 16, 2010 | AliMed Corporation Product is a pull cord type monitor, bed patient alarm used to detect patient/resident movement. An adjustable cord is attached to both the alarm and the patient. When the patient moves beyond the le Terminated |
KMI | None listed |
| Jan 13, 2009 | Sterilmed Inc Bed Check
Model #'s:
BED65815-021
BED65815-025
BED65815-025IT
BED65815-030
BED65815-031
BED73000
BED73010
BED74000
BED74010
NURBPP-30A
NURBPP-30WC
POS8283
RFT1000-1210
RFT1000-1250
RFT1000-1810 and
R Terminated |
KMI | None listed |
| Jan 24, 2008 | Hoana Medical Hoana LifeBed Patient Vigilance System, (Intelligent Medical Vigilance System),Model Number: 010135-01, Product distributed by Hoana Medical, Inc., 828 Fort St. Mall, Suite 620,
Honolulu, HI Terminated |
KMI | None listed |
| Apr 25, 2003 | General Electric Medical Systems Information Technology MAC-LAB (Classic) systems Terminated |
KMI | None listed |
| Apr 25, 2003 | General Electric Medical Systems Information Technology MAC-LAB 5000EX systems Terminated |
KMI | None listed |
| Apr 25, 2003 | General Electric Medical Systems Information Technology MAC-LAB 3000EX systems Terminated |
KMI | None listed |
| Apr 25, 2003 | General Electric Medical Systems Information Technology MAC-LAB 1000EX systems Terminated |
KMI | K021366 |
| Jan 16, 2003 | RF Technologies, Inc. Bed/chair alarm Terminated |
KMI | None listed |
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