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510(k) Data Aggregation

    K Number
    K231506
    Device Name
    Current Health System
    Manufacturer
    Current Health Ltd
    Date Cleared
    2023-08-24

    (92 days)

    Product Code
    MSX, BZG, BZQ, DQA, DRG, FLL
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Current Health Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Current Wearable Health Monitoring System is intended for reusable bedside, mobile and central multi-parameter, physiologic monitoring of patients aged 14 years old and above in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals. The Current Wearable Health Monitoring System is intended to provide visual and audible physiologic multi-parameter alarms. The Current Wearable Health Monitoring System is intended for temperature monitoring temperature at the upper arm is clinically indicated. The Current Wearable Health Monitoring System is intended for continuous monitoring of the following parameters: - · Pulse rate - · Oxygen saturation - · Temperature - Movement The Current Wearable Health Monitoring System is intended for intermittent or spot-check monitoring of: - · Respiration rate - · Non-invasive blood pressure - · Lung function & spirometry - · Weight The Current Wearable Health Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms. The Current Wearable Health Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The Current Wearable Health Monitoring System is not a substitute for an ECG monitor. The Current Wearable Health Monitoring System is not intended for SpO2 monitoring in conditions of high motion or low perfusion.
    Device Description
    The Current Wearable System is a remote patient monitoring system that consists of a monitoring device (the wearable) worn on the upper arm by 14 years old and above patients, a software platform (containing the alarming system) and a user interface to allow presentation of vital signs data both on mobile devices and web-based dashboard. The Current Wearable System is also integrated with third-party devices for displaying and monitoring physiological signs. The Wearable is intended to continuously monitors physiological vital sign data from the person being monitored and securely transmit the encrypted data via the secure server. The wearable is intended for use in professional healthcare facilities, such as hospitals or skilled nursing facilities, or the home by trained healthcare professionals. The healthcare professional can securely access the patient physiological signs remotely via a mobile application or a web-interface which is also intended to provide visual and audible physiologic multi-parameter alarms.
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    K Number
    K222550
    Device Name
    Current Health System
    Manufacturer
    Current Health Ltd.
    Date Cleared
    2022-11-01

    (70 days)

    Product Code
    MSX, BZG, BZQ, DQA, DRG, FLL
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Current Health Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Current Wearable Health Monitoring System is intended for reusable bedside, mobile and central multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals. The Current Wearable Health Monitoring System is intended to provide visual and audible physiologic multi-parameter alarms. The Current Wearable Health Monitoring System is intended for temperature monitoring where monitoring temperature at the upper arm is clinically indicated. The Current Wearable Health Monitoring System is intended for continuous monitoring of the following parameters in adults: - · Pulse rate - · Oxygen saturation - · Temperature - Movement The Current Wearable Health Monitoring System is intermittent or spot-check monitoring, in adults, of. - · Respiration rate - Non-invasive blood pressure - · Lung function & spirometry - · Weight The Current Wearable Health Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms. The Current Wearable Health Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The Current Wearable Health Monitoring System is not a substitute for an ECG monitor. The Current Wearable Health Monitoring System is not intended for SpO2 monitoring in conditions of high motion or low perfusion.
    Device Description
    The Current Wearable System is a remote patient monitoring system that consists of a monitoring device (the wearable) worn on the upper arm by adult patients (aged 18 years old and over), a software platform (containing the alarming system) and a user interface to allow presentation of vital signs data both on mobile devices and web-based dashboard. The Current Wearable System is also integrated with third-party devices for displaying and monitoring physiological signs. The Wearable is intended to continuously monitors physiological vital sign data from the person being monitored and securely transmit the encrypted data via the secure server. The wearable is intended for use in professional healthcare facilities, such as hospitals or skilled nursing facilities, or the home by trained healthcare professionals. The healthcare professional can securely access the patient physiological signs remotely via a mobile application or a web-interface which is also intended to provide visual and audible physiologic multi-parameter alarms.
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    K Number
    K191272
    Device Name
    Wearable Device, Wearable Package
    Manufacturer
    Current Health Ltd.
    Date Cleared
    2019-07-12

    (60 days)

    Product Code
    MSX, BZG, BZQ, DQA, DRG, FLL
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Current Health Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Current Wearable Health Monitoring System is intended for reusable bedside, mobile and central multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals. The Current Wearable Health Monitoring System is intended to provide visual and audible physiologic multi-parameter alarms. The Current Wearable Health Monitoring System is intended for temperature monitoring where monitoring temperature at the upper arm is clinically indicated. The Current Wearable Health Monitoring System is intended for continuous monitoring of the following parameters in adults: - · Pulse rate - · Oxygen saturation - · Temperature - · Movement The Current Wearable Health Monitoring System is intermittent or spot-check monitoring, in adults, of. - · Respiration rate - · Non-invasive blood pressure - · Lung function & spirometry - · Weight The Current Wearable Health Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms. The Current Wearable Health Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The Current Wearable Health Monitoring System is not a substitute for an ECG monitor. The Current Wearable Health Monitoring System is not intended for SpO2 monitoring in conditions of high motion or low perfusion.
    Device Description
    The Current Wearable Health Monitoring System consists of a single monitoring device worn on the upper arm, a software platform (containing an alarming system) and a user interface to allow presentation of vital signs data both on mobile devices and a central station. The Current Wearable Health Monitoring System is also integrated with devices for monitoring of blood pressure, spirometry & lung function, and weight. The system is intended to continuously monitor adult patient vital signs in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals. It is intended to continuously monitor pulse rate (PR), oxygen saturation (SpO2), temperature (TEMP) and movement (MOVEMENT). Current is intended for intermittent or spot-checking monitoring of respiration rate (RESP), blood pressure (BP), spirometry & lung function, and weight (WEIGHT). While the wearable device monitors skin temperature, an additional adhesive axillary sensor can be used to monitor axillary temperature. In the home environment, the patient will have responsibility for applying the device to their arm, charging the device and plugging in the Homehub to mains power. However, the data will still be made directly available to healthcare professionals. These healthcare professionals will be at a remote location e.g. an office or within the hospital or could be with the patient in their own home.
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    K Number
    K190073
    Device Name
    Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub
    Manufacturer
    Current Health Ltd
    Date Cleared
    2019-03-27

    (70 days)

    Product Code
    MSX, BZQ, DQA, DRG, FLL
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Current Health Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Current Wearable Health Monitoring System is intended for reusable bedside, mobile and central multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals. The Current Wearable Health Monitoring System is intended to provide visual and audible physiologic multi-parameter alarms. The Current Wearable Health Monitoring System is intended for temperature monitoring temperature at the upper arm is clinically indicated. The Current Wearable Health Monitoring System is intended for continuous monitoring of the following parameters in adults: - · Pulse rate - · Oxygen saturation - · Temperature - Movement The Current Wearable Health Monitoring System is intermittent or spot-check monitoring of respiration rate, non-invasive blood pressure and weight in adults. The Current Wearable Health Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms. The Current Wearable Health Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmas e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The Current Wearable Health Monitoring System is not a substitute for an ECG monitor. The Current Wearable Health Monitoring System is not intended for SpO2 monitoring in conditions of high motion or low perfusion.
    Device Description
    The Current Wearable Health Monitoring System consists of a single monitoring device worn on the upper arm, a software platform (containing an alarming system) and a user interface to allow presentation of vital signs data both on mobile devices and a central station. The Current Wearable Health Monitoring System is also integrated with specific devices for monitoring of blood pressure and weight. The system is intended to continuously monitor adult patient vital signs in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals. It is intended to continuously monitor pulse rate (PR), oxygen saturation (SpO2), temperature (TEMP) and movement (MOVEMENT). Current is intended for intermittent or spot-checking monitoring of respiration rate (RESP), blood pressure (BP) and weight (WEIGHT). In the home environment, the patient will have responsibility for applying the device to their arm, charging the device and plugging in the Homehub to mains power. However, the data will still be made directly available to healthcare professionals. These healthcare professionals will be at a remote location e.q. an office or within the hospital or could be with the patient in their own home.
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