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510(k) Data Aggregation

    K Number
    K002390
    Manufacturer
    Date Cleared
    2000-11-02

    (90 days)

    Product Code
    Regulation Number
    890.5880
    Reference & Predicate Devices
    Why did this record match?
    Reference Devices :

    K993461

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Quantum Intersegmental Roller Traction Table uses a roller mechanism and electric motors coupled with vibration and optional heat to release muscle tension and deliver soothing massage by the movement of the roller carriage back and forth from the cervical area to the lumbar area of the patient.

    Device Description

    The Quantum Intersegmental Roller Traction Table features three six inch wide, six inch diameter rollers which rotate in a clockwise or counter-clockwise direction while tracking up and down the back. The roller height can be adjusted to place varying degrees of pressure on the muscles of the back while the patient is lying in the supine position.

    AI/ML Overview

    This document is a 510(k) summary for the Quantum Intersegmental Roller Traction Table. It claims substantial equivalence to a predicate device and states the intended uses. However, it does not include information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies. Therefore, I cannot provide the requested information.

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