Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K121757
    Device Name
    HEALTHMATEFOREVER
    Manufacturer
    HEALTHMATE INTERNATIONAL, LLC
    Date Cleared
    2012-11-20

    (158 days)

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

    HEALTHMATE INTERNATIONAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TENS: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS: It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
    Device Description
    Pro-8AB is portable; battery powered (3.7V DC) multi-function device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities in one device. Double or single channel that effectively transfer your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle contractions. There are 6 modes of operations.
    Ask a Question

    Page 1 of 1