KMI · Monitor, Bed Patient
General Hospital · 21 CFR 880.2400 · Class 1
Overview
| Product Code | KMI |
|---|---|
| Device Name | Monitor, Bed Patient |
| Regulation | 21 CFR 880.2400 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
Identification
A bed-patient monitor is a battery-powered device placed under a mattress and used to indicate by an alarm or other signal when a patient attempts to leave the bed.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
Recent Cleared Devices (20 of 31)
Showing 20 most recent of 31 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K141877 | LEAF PATIENT MONITORING SYSTEM | Leaf Healthcare, Inc. | Nov 10, 2014 | SESE |
| K131585 | INTEL-GE CARE INNOVATIONS QUIETCARE | Intel-Ge Care Innovations, LLC | Oct 8, 2013 | SESE |
| K130752 | DYNASENSE SYSTEM | Centauri Medical, Inc. | Aug 15, 2013 | SESE |
| K101109 | VIVATRAK | Wireless Medcare, LLC | Jul 15, 2010 | SESE |
| K090138 | MOBILECARE MONITOR, MODEL 2100 | Aframe Digital, Inc. | Apr 24, 2009 | SESE |
| K942770 | ULTIMAT-SENSOR FOR BED OCCUPANCY MONITOR | Ultimate Development Corp. | Dec 23, 1994 | SESE |
| K943481 | INFORMER PLUS | Micro-Tech Medical, Inc. | Nov 2, 1994 | SESE |
| K933552 | PM-PAGER | Hill Engineering | Sep 22, 1994 | SESE |
| K934344 | HOME AMB-ALERT | Medway | Apr 29, 1994 | SESE |
| K940405 | TELETOM | Berchtold Holding GmbH | Apr 14, 1994 | SESE |
| K924433 | SENIOR TECH TABS 88 TRANS RA1/WRA1/R1 ANN TYPE CR1 | Senior Technologies, Inc. | Jun 24, 1993 | SESE |
| K925529 | WANDER CARE | Care Electronics, Inc. | Jun 16, 1993 | SESE |
| K920206 | POSEY SITTER | J. T. Posey Co. | May 14, 1992 | SESE |
| K914859 | BARTRONIX IN-BED ACTIVITY MONITOR | Bartronix | Apr 13, 1992 | SESE |
| K911079 | AMB-ALERT | Medway | Sep 13, 1991 | SESE |
| K905586 | RSVP RF-2000 | Tactilitics, Inc. | Apr 1, 1991 | SESE |
| K905421 | EXIT ALARM | Alertcare | Feb 12, 1991 | SESE |
| K901969 | ALERT BED ALARM SYSTEM | Alertronics, Inc. | Sep 12, 1990 | SESE |
| K901330 | THE MONITOR ELECTRONIC BED ALARM SYSTEM | The Monitor Corp. | Aug 30, 1990 | SESE |
| K883390 | PMD SYSTEM-20 | Datatek, Inc. | Oct 25, 1988 | SESE |
Top Applicants
- Fsm Corp. — 2 clearances
- Medway — 2 clearances
- Tactilitics, Inc. — 2 clearances
- Aframe Digital, Inc. — 1 clearance
- Alertcare — 1 clearance
