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510(k) Data Aggregation

    K Number
    K040905
    Device Name
    WELLNESS/JOLIVETE
    Manufacturer
    TOHKAI PRECISION IND. LTD.
    Date Cleared
    2005-02-23

    (322 days)

    Product Code
    IRP
    Regulation Number
    890.5650
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    K092435
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    By individuals or clinicians, to provide temporary relief from localized aches, pains and / or swelling caused by poor circulation, muscular stress or edema. May also be used to temporarily relieve symptoms of lymphoedema.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a massaging device. This document does not contain information about acceptance criteria, study data, sample sizes, expert qualifications, or any of the other specific details you requested regarding a device's performance study. It only states that the device is substantially equivalent to a legally marketed predicate device.

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