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510(k) Data Aggregation
K Number
K141877Device Name
LEAF PATIENT MONITORING SYSTEM
Manufacturer
LEAF HEALTHCARE, INC.
Date Cleared
2014-11-10
(122 days)
Product Code
KMI, MON
Regulation Number
880.2400Why did this record match?
Applicant Name (Manufacturer) :
LEAF HEALTHCARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Leaf Patient Monitoring System monitors the orientation and activity of patients susceptible to pressure ulcers. It allows healthcare providers to implement individualized turn management plans and continuously monitor each patient. The Leaf Patient Monitoring System provides alerts when patient orientation or activity deviates from parameters set by healthcare providers. The device is intended for use in medical, nursing and long-term care facilities, including independent living, assisted-living and rehabilitation facilities.
Device Description
The Leaf Patient Monitoring System is a medical device designed for use in hospitals, nursing homes, or other patient care facilities to monitor and report body orientation and activity, as well as to provide visual alerts for orientations and activity levels that fall outside of thresholds set by healthcare providers. The use of the Leaf Patient Monitoring System provides for continuous monitoring of patient position and allows caregivers to easily identify patients that are in need of caregiver-assisted turns according to the institution's guidelines or protocols. The use of the Leaf Patient Monitoring System can increase compliance with the care facility's prescribed patient tuning schedule and thereby may aid in the prevention of pressure ulcers.
The Leaf Patient Monitoring System is comprised of Patient Sensors, Leaf Antennas, and USB RF Transceivers, Turn Management Software, and a User Interface that can be viewed on a monitoring station. Each Leaf Patient Sensor is associated with a single patient, such that the patient's orientation, movements, and other care parameters can be monitored.
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