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510(k) Data Aggregation

    K Number
    K182581
    Device Name
    PlayMakar Sport Muscle Stimulator, Model PRO-500
    Manufacturer
    Date Cleared
    2018-11-21

    (63 days)

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

    PlayMakar Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P1 through P6) For temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 through P3) For temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 through P3) For symptomatic relief and management of chronic, intractable pain associated with arthritis. (Choose TENS Mode P4)
    Device Description
    Not Found
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