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510(k) Data Aggregation

    K Number
    K032505
    Device Name
    AIR PRESS MASSAGER
    Manufacturer
    TELEBRANDS CORP
    Date Cleared
    2003-09-24

    (42 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 :

    AIR PRESS MASSAGER

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

    The Air Press Massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people with good health. The Air Press simulates kneading and stroking of tissues by using an inflatable garment.

    Device Description

    The Air Press simulates kneading and stroking of tissues by using an inflatable garment.

    AI/ML Overview

    This document is a 510(k) clearance letter for the Telebrand Air Press Massager. It addresses the device's substantial equivalence to a legally marketed predicate device, but it does not contain any information regarding acceptance criteria, device performance studies, or clinical trial details.

    Therefore, I cannot provide the requested information. The letter primarily confirms that the FDA has reviewed the premarket notification and determined that the device can be marketed subject to general controls of the Federal Food, Drug, and Cosmetic Act.

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