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510(k) Data Aggregation
K Number
K050234Device Name
REMOTE CARE
Manufacturer
Date Cleared
2005-08-25
(205 days)
Product Code
Regulation Number
884.2740Why did this record match?
Applicant Name (Manufacturer) :
E.CARE SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Remote Care is a patient management web based application device for use with the Analogic FETALGARD Lite™ to record and graphically display maternal abdominal contractions and the fetal heart rate by means of a display in the format of a graphic or PDF strip file. The data is intended to aid in assessing the well being of the fetus during the final trimester of pregnancy (Non-Stress Test). This device is for trained medical personnel located in hospitals, clinics, doctor's offices and in the patient's home.
Remote Care is intended to be used only with the Analogic Fetalgard Lite to assist in the transmission and graphical display of maternal abdominal contractions and fetal heart rate. Remote Care receives the strip data from the monitoring system via a modem or the CareStation video phone. This strip data is then transmitted to the Remote Care web site for viewing by the health care provider.
Remote Care does not provide real-time capabilities or alerts. The device is intended for use to communicate strip data which can be used to aid in assessing the well being of the fetus in the final trimester of pregnancy. Healthcare professionals must apply clinical judgment and experience to assess the data transmitted. The device is not intended as a replacement for professional medical care. It should not be used for patients requiring emergency intervention.
Device Description
Remote Care is an internet database application and repository for the storage and archival of patient information with their physiological data that relates to the Remote Care OB customers' prenatal experience. "Remote Care" receives data from the Analogic FETALGARD Lite™ and makes the data available to the medical professional through the World Wide Web.
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