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510(k) Data Aggregation

    K Number
    K211365
    Device Name
    Alio Medical Remote Monitoring System
    Manufacturer
    Graftworx, Inc. dba Alio
    Date Cleared
    2022-03-24

    (324 days)

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

    Graftworx, Inc. dba Alio

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Alio Medical Remote Monitoring System is a wireless remote monitoring system intended for use by healthcare professionals to intermittently collect physiological data in home use settings. The data includes skin temperature, auscultation sound data and heart rate. Data is transmitted wirelessly from the SmartPatch wearable sensor to a web-based portal for the healthcare provider's (HCP) review. The Alio Medical RMS is intended for use on general care patients who are 18 years of age or older. The SmartPatch sensor is indicated to measure skin temperature and pulse rate where clinically indicated. The SmartPatch sensor is indicated to record and transmit auscultation sound data where clinically indicated. The device is not intended for use in critical care or other high-acuity environments. The Alio Medical RMS is a secondary, adjunct patient monitor and is not intended to replace existing standard-of-care patient monitoring practices.
    Device Description
    Alio Medical Remote Monitoring System, or "Alio Medical RMS", utilizes a wearable device (SmartPatch) on the skin to gather physiological data and then transmits it to a device (Bedside Hub) located in the subject's home. The Bedside Hub then relays this raw data to the Alio Medical Cloud where it is processed and analyzed using Alio's proprietary algorithms. Data is accessible to Healthcare Professionals and the Alio clinical team via a web-based Clinician Portal. The SmartPatch and Bedside Hub are intended to be used on general care patients who are 18 years of age or older in a non-clinical environment. The web-based Clinical Portal is to be used by healthcare professionals in an office environment. The Alio Medical Remote Monitoring System includes the following components: - SmartPatch - Bedside Hub - Alio Medical Cloud (backend only - not user facing) - Clinician Portal SmartPatch: A flexible, silicone-encased patch that can be worn where clinically indicated for up to seven days at a time. It houses numerous sensor technologies, which include a microphone, accelerometer, temperature sensors, and a PPG sensors collect physiological data including skin temperature, auscultation sound data, and heart rate. Data is transmitted to the Cloud, via the Hub, where it is analyzed and sent to a Healthcare Professional via the Web Portal. Bedside Hub: The Bedside Hub has the form and finish of an at-home device. It automatically communicates with the activated SmartPatch and uploads physiological data to the Alio Medical Cloud. Alio Medical Cloud: The Cloud features a database that supports storage, analytics, system monitoring and visualization capabilities. The Alio Medical Cloud is encrypted and HIPAA compliant. All patient data is fully traceable to device and patient ID via the database. Clinician Portal: The Clinician Portal is the interface tool between a user (healthcare professional users only) and the system that enables the user to visualize and interact with data being generated by the system.
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