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510(k) Data Aggregation

    K Number
    K050174
    Device Name
    BIO-STIM KIT
    Manufacturer
    SKYLARK DEVICE & SYSTEMS CO., LTD
    Date Cleared
    2005-09-07

    (225 days)

    Product Code
    GZJ,NUH
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BIO-STIM KIT

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

    This BIO-STIM KIT is intended for temporary relief of pain associated with sore and aching muscle in the lower back due to strain from exercise or normal household and work activities.

    Device Description

    Not Found

    AI/ML Overview

    This is a scanned FDA 510(k) clearance letter for the "BIO-STM KIT", a transcutaneous electrical nerve stimulator for pain relief. The document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices and therefore can be marketed. It does not include performance data or studies.

    Therefore, I cannot provide the requested information.

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