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510(k) Data Aggregation

    K Number
    K233827
    Device Name
    OxiWear
    Manufacturer
    Date Cleared
    2024-08-28

    (271 days)

    Product Code
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    OxiWear, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OxiWear system is indicated for non-invasive, spot-checking and/or continuous data collection of adult (22+) and adolescent (12-21) patients who are well or poorly perfused, during motion conditions. It is intended for use in hospitals, medical facilities, home healthcare environments, and mobile environments. The recommended application site is the helix of the ear.
    Device Description
    The OxiWear System is an ear pulse oximeter that non-invasively measures and displays patient blood oxygen saturation (SpO2) and Pulse Rate for spot-checking and/or continuous data collection. The OxiWear System is intended to be used with well or poorly perfused patients of all skin types in both motion conditions. The system is intended for use in clinical and home environments for adult (22+) and adolescent (12-21) patients of all skin types who are well or poorly perfused, and can safely wear the oximeter device on the helix of the OxilVear System can be used with patients that are in both motion and stationary conditions. The OxilVear System contains the OxilVear Wearable, and the OxiMear Mobile Application. The OxiMear Wearable is a wireless, reusable, non-invasive ear pulse oximeter that is intended to measure SpO2 and Pulse Rate based on the amount of transmitted, reflected light through the ear. The OxiWear Wearable is powered by an internal rechargeable lithium ion battery, and attaches directly to the ear. The OxilVear Wearable is intended to be recharged by the OxiWear Charger, which is a rechargeable portable charger, The OxiMear Wearable is designed to be used with the OxiMeation which receives data from the OxiMear Wearable via Bluetooth connection to the user's smart phone. The OxiMear Mobile Application acts as a historical trending, live data monitoring, and text alert application is intended to be used alongside the OxiWear Wearable during daily use, as well as a data repository to refer back to previous reports containing information about the patient, pulse rate, patient contacts, and more, to present to a physician or caregiver for review.
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