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510(k) Data Aggregation

    K Number
    K962951
    Device Name
    MODEL HS-2 TENS DEVICE
    Date Cleared
    1997-08-06

    (376 days)

    Product Code
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECHNALITHICS LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sportstim 2.0 can only be used upon the prescription of a physician for the symptomatic relief of chronic intractable pain, including the relief of post-traumatic and post-surgical pain.
    Device Description
    Not Found
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