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510(k) Data Aggregation

    K Number
    K992120
    Device Name
    DYNAWELL OR DYNAWELL
    Manufacturer
    EKEROTH QUALITY AB
    Date Cleared
    1999-08-13

    (51 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    K070968
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Accessory for axial compression of the Lumbar spine in CT and MR Indication For Use. "Accessory for was vempresses during research and clinical purposes.

    Device Description

    Through compression of the spine with a Harness, two cords and a foot part improve CT and MR diagnostic of the spinal canal.

    AI/ML Overview

    I am sorry, but the provided text does not contain information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, or details about any studies conducted (e.g., standalone, MRMC) for the DynaWell device.

    The document is a 510(k) summary, which primarily focuses on establishing substantial equivalence to a predicate device. It provides:

    • Device Description: What the DynaWell is and how it functions (compression of the spine for improved CT/MR diagnostics).
    • Intended Use: Criteria for when to use the device (e.g., neurogenic claudication, suspected dural sac deformation) and contraindications (e.g., vertebral trauma, osteoporosis).
    • Regulatory Information: FDA's 510(k) clearance letter and the "Indication For Use" statement.

    To answer your request, I would need a document that specifically details the performance evaluation, clinical studies, and acceptance criteria for the DynaWell device.

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