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510(k) Data Aggregation
K Number
K130752Device Name
DYNASENSE SYSTEM
Manufacturer
CENTAURI MEDICAL, INC.
Date Cleared
2013-08-15
(149 days)
Product Code
KMI, MON
Regulation Number
880.2400Why did this record match?
Applicant Name (Manufacturer) :
CENTAURI MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DynaSense monitors orientation and activity of patients susceptible to pressure ulcers. It allows healthcare providers to implement individualized turn management plans and continuously monitor each patient. DynaSense 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
DynaSense is a patient monitoring system that has been designed for use in hospitals, nursing homes, or other patient care facilities to aid standard care procedures for patients who are susceptible to pressure ulcers. The system monitors and reports patient activity and orientation as well as alerts the user (i.e., healthcare provider) when activity levels deviate from parameters set by healthcare providers. DynaSense is comprised of Patient Sensors, Relay Antennas, a USB RF Transceiver, Mesh Network Server Software, and User Interface software.
Each Patient Sensor is associated with a single patient, such that the patient's orientation and activity can be monitored. Data collected by the Patient Sensor is automatically communicated wirelessly to a nearby Relay Antenna, which subsequently relays these data to be displayed on the User Interface and maintained in a database. The system's Relay Antennas that are plugged into electrical outlets on the walls of the facility and the USB RF Transceiver that is plugged into the computer, on which the Mesh Network Server Software is installed or accessed, form a wireless network that allows data to be transmitted for display. The Mesh Network Server Software manages this network of Relay Antennas and USB RF Transceiver and collects the data from the Patient Sensors to allow monitoring of multiple patients on a single screen within the User Interface.
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