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510(k) Data Aggregation

    K Number
    K190015
    Device Name
    Ballancer Gold, 1212
    Manufacturer
    Mego Afek AC Ltd.
    Date Cleared
    2019-03-25

    (81 days)

    Product Code
    IRP
    Regulation Number
    890.5650
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Ballancer Gold, 1212

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

    Ballancer® Gold is a pneumatic massage system intended to provide gradient pressure in areas to which the inflatable garment is applied.

    The Ballancer Gold is indicated for:

    • · Simulate kneading and stroking of the tissues by use of an inflatable garment.
    • · Temporary increase circulation in the areas which the garment is applied
    • · Temporary relief of minor muscle aches and pains
    Device Description

    Ballancer® Gold, Model 1212 is a pneumatic massage system.

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the Ballancer® Gold, Model 1212. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily confirms that the device is substantially equivalent to a predicate device and outlines regulatory compliance requirements.

    Therefore, I cannot provide the requested information based on the input document. The document primarily focuses on regulatory clearance rather than detailed performance study results.

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