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510(k) Data Aggregation

    K Number
    K200537
    Device Name
    Oxxiom
    Date Cleared
    2020-07-03

    (122 days)

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

    True Wearables, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Oxxiom Pulse Oximetry System is a wireless, fully disposable, single-use indicated for measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). It may be used for spot checking, intermittent monitoring, and/or data collection of patients 12 years and older in low acuity settings in facilities such as hospitals, clinics and doctor's offices. It can also be used in home healthcare settings under prescription use. It is not intended for continuous monitoring.
    Device Description
    Oxxiom Pulse Oximetry System is a wireless, fully disposable, single-use device for measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). lt also measures Pulse Amplitude (PA). It is a prescription device for spot checking, intermittent monitoring, and data collection. Oxxiom has two main components, the Oxxiom device (hardware device) and the Oxxiom Rx App. Oxxiom also provides tape to apply the device to the finger. Oxxiom also requires the use of an iOS display device, such as an iPhone, iPad, or iPod, that has iOS version 10.1 or later. The iOS device is not provided with the Oxxiom Pulse Oximetry System. Oxxiom is small, lightweight, and has a 24-hour battery life. The device simultaneously, and wirelessly transfers all collected data through a Bluetooth connection to the Oxxiom App on the iOS device, which analyzes data, displays information, provides warnings as necessary, and stores the information. Oxxiom has been tested on a subject population with devices placed on the finger. Monitoring at other sites of the body is not recommended. The principle of operation is based upon the noninvasive reflectance of red and infrared light.
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