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510(k) Data Aggregation

    K Number
    K123020
    Device Name
    BLIP MODEL BP-700WF
    Manufacturer
    CAREMATIX INC.
    Date Cleared
    2012-11-28

    (61 days)

    Product Code
    DXN, DRG
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAREMATIX INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BP 700-WF is a non-invasive blood pressure measurement device intended to measure systolic, diastolic BP 700-Wr is a non-invasive blood pressure modult individual over age 18, at home by using a non-invasive blood pressure and puise rate of an addit managed around the upper arm. The cuff circumference is limited to 9"-13" for Arm type. The device can transmit the readings through wireless communication for record archiving and review.
    Device Description
    Not Found
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    K Number
    K100508
    Device Name
    CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B
    Manufacturer
    CAREMATIX INC.
    Date Cleared
    2010-05-05

    (72 days)

    Product Code
    DRG, CLA
    Regulation Number
    870.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAREMATIX INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Carematix™ Wellness System is a physiological monitoring system. The system collects, accumulates and transmits patient vital signs and other physiological data from a patient who may be remote from the healthcare practitioner to the practitioner. It is intended for patient home use for the following and can record physiological information such as: Non-invasive blood pressure measurement; Pulse rate measurement; Blood glucose level using a Glucometer; Blood hemoglobin oxygen saturation (%SpO2) using a digital Pulse Oximeter; Prothrombin Time (PT) and International Normalized Ratio (INR) measurement using an inhome coagulation measurement system; Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume (FEV) measurements using an electronic peak flow meter; Patient weight using a stand-on electronic scale The results of these measurements are transmitted to a computer monitoring station in a clinical setting via common telephone lines from the patient's home setting.
    Device Description
    The Carematix™ Wellness System is intended to gather and transmit patient data from the home site or remote location to caregivers at a clinical facility where it provides supplemental information for the care of the patient. The Carematix™ Wellness System consists of wireless radiofrequency transmitter adapters, a communication hub or receiving station, and an internet server: - The radiofrequency transmitter adapter is connected, either wired directly or to . a serial port, of monitoring devices currently in distribution having capability to monitor patient parameters for blood pressure, pulse rate, blood sugar, blood oxygen saturation, PT/INR, and FEV/PEFR. - The communications hub, or receiving station, collects and stores data transmitted from each of the radiofrequency transmitter adapters or wired device and transmits patient data to the internet server via PSTN. LAN. cellular, wireless etc. - The internet server receives the patient data from the home setting or remote . location where it is made available to the caregiver to track, graph, note variances, set alert criteria, and receive notifications when parameters are outside the criteria set.
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    K Number
    K073038
    Device Name
    CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B
    Manufacturer
    CAREMATIX INC.
    Date Cleared
    2008-01-11

    (74 days)

    Product Code
    DRG
    Regulation Number
    870.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAREMATIX INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Carematix™ Wellness System is a physiological monitoring system. The system collects, accumulates and transmits patient vital signs and other physiological data from a patient who may be remote from the healthcare practitioner to the practitioner. It is intended for patient home use for the following and can record physiological information such as: Non-invasive blood pressure measurement: Pulse rate measurement; Blood glucose level using a Glucometer; Blood hemoglobin oxygen saturation (%SpO2) using a digital Pulse Oximeter; Prothrombin Time (PT) and International Normalized Ratio (INR) measurement using an inhome coagulation measurement system: Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume (FEV) measurements using an electronic peak flow meter; Patient weight using a stand-on electronic scale The results of these measurements are transmitted to a computer monitoring station in a clinical setting via common telephone lines from the patient's home setting.
    Device Description
    The Carematix™ Wellness System is intended to gather and transmit patient data from the home site or remote location to caregivers at a clinical facility where it provides supplemental information for the care of the patient. The Carematix™ Wellness System consists of wireless radiofrequency transmitter adapters, a communication hub or receiving station, and an internet server: - The radiofrequency transmitter adapter is connected, either wired directly or . to a serial port, of monitoring devices currently in distribution having capability to monitor patient parameters for blood pressure, pulse rate, blood sugar, blood oxygen saturation, PT/INR, and FEVR/PEF. - The communications hub, or receiving station, collects and stores data . transmitted from each of the radiofrequency transmitter adapters and transmits patient data to the internet server at specified intervals. - . The internet server receives the patient data from the home setting or remote location where it is made available to the caregiver to track, graph, trend, note variances, set alert criteria, and receive alerts when parameters are outside . the criteria set.
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    K Number
    K040966
    Device Name
    MODIFICATION TO CAREMATIX WELLNESS SYSTEM
    Manufacturer
    CAREMATIX INC.
    Date Cleared
    2004-06-02

    (49 days)

    Product Code
    DRG
    Regulation Number
    870.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAREMATIX INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Carematix Wellness System is a physiological monitoring system. The system collects, accumulates and transmits patient vital signs and other physiological data from a patient who may be remote from the healthcare practitioner to the practitioner. It is intended for patient home use for the following and can record physiological information such as: Non-invasive blood pressure measurement; Pulse rate measurement; Blood glucose level using a Glucometer; Blood hemoglobin oxygen saturation (%SpO2) and pulse rate using a digital Pulse Oximeter; Prothrombin Time (PT) and International Normalized Ratio (INR) measurement using an in-home coagulation measurement system; Body temperature measurement using a digital thermometry device or system; Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume (FEV) measurements using an electronic peak flow meter; Patient weight using a stand-on electronic scale. The results of these measurements are transmitted to a computer monitoring station in a clinical setting via common telephone lines from the patient's home setting.
    Device Description
    The Carematix Wellness System (CWS) provides easy monitoring of the basic wellness parameters via a wireless connection between the monitoring device and a hub (receiving station) located in the home. The hub transmits the information to the Carematix Internet server where the data is added to the patient's chart. Using a web-browser, the caregiver can track the patient's data, graph the results, monitor trends, annotate variances, set alert criteria, and send reminders and receive alerts via e-mail or pager. The following monitoring devices are currently available from Carematix: Blood pressure unit (Arm cuff and Wrist cuff), Weight Scale, Blood Glucose Meter adaptors, Pulse Oximeter adaptors, Coagulation Measurement System adaptors, Digital Thermometer adaptors, Peak Flow Meter adaptors.
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    K Number
    K031840
    Device Name
    CAREMATIX WELLNESS SYSTEM
    Manufacturer
    CAREMATIX INC.
    Date Cleared
    2003-10-10

    (116 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAREMATIX INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Carematix Wellness System is intended for patient home use for the following: Non-invasive blood pressure measurement; Measurement of blood glucose; Patient weight using a stand-on electronic scale The results of these measurements are transmitted to a computer monitoring station in a clinical setting via common telephone lines from the patient's home setting. Prescription Device. Federal law (US) restricts this device to sale by or on the order of a physician.
    Device Description
    The Carematix Wellness System (CWS) provides easy monitoring of the basic wellness parameters via a wireless connection between the monitoring device and a hub (receiving station) located in the home. The hub transmits the information to the Carematix Internet server where the data is added to the patient's chart. Using a web-browser, the caregiver can track the patient's data, graph the results, monitor trends, annotate variances, set alert criteria, and send receive alerts via e-mail or pager. The following monitoring devices are currently available from Carematix: Blood pressure unit (Arm cuff and Wrist cuff), Weight Scale, Blood Glucose Meter adaptors.
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