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510(k) Data Aggregation

    K Number
    K150269
    Device Name
    Ballancer 505 System, Model 1201-AC
    Manufacturer
    Mego Afek AC Ltd.
    Date Cleared
    2015-05-26

    (111 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 505 System, Model 1201-AC

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

    Ballancer 505 is a pneumatic massage system intended to provide gradient pressure in areas, which the inflatable garment is applied.

    The Ballancer 505 System is indicated for:

    • Simulating kneading and stroking of the tissues by use of an inflatable garment

    • Temporary increase circulation in areas which the garment is applied

    • Temporary relief of minor muscle aches and pains

    Device Description

    Ballancer® 505 System, Model 1201-AC is a pneumatic massage system.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria and device performance study details. The text is a letter from the FDA regarding a 510(k) premarket notification for the Ballancer 505 System, Model 1201-AC, and includes its indications for use. It does not include a detailed study report or acceptance criteria for device performance.

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