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510(k) Data Aggregation

    K Number
    K232023
    Device Name
    Momentum Spine
    Date Cleared
    2023-10-04

    (89 days)

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

    Momentum Health Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Momentum Spine app is an optical contour sensing mobile application intended to quantify asymmetries, assess body angles and curve progression related to postural asymmetries, including scoliosis. The device is available directly to lay users (Over-the-Counter) and may also be prescribed for use by physicians. The device is intended for use in patients 8 years and older.
    Device Description
    Momentum Spine is an optical contour sensing mobile application intended to quantify asymmetries, assess body angles and curve progression related to postural asymmetries, including scoliosis. The device is available directly to lay users (Over-the-Counter) and may also be prescribed for use by physicians. From a simple video taken on a mobile device. Momentum Spine ('app') reconstructs a 3D model of the torso to quantify asymmetry using 3D imaging and artificial intelligence. The app is intended to be used by a combination of lay users (parents, guardians etc.) and health care professionals. The patients do not use the device on themselves. The app is intended to be used on patients 8 years and older to scan and monitor postural asymmetries. The app can be used by patient populations suffering from postural deformities mainly scoliosis. Additionally, the device can also be used by an otherwise healthy population to scan for and monitor their overall spinal health.
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