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510(k) Data Aggregation

    K Number
    K130052
    Device Name
    TONE-A-MATIC
    Date Cleared
    2013-12-20

    (345 days)

    Product Code
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    TONE-A-MATIC INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Tone-A-Matic is indicated to be used for - · Russian and EMS for: - o Relaxation of muscle spasms - Prevention or retardation of disuse atrophy o - Increase local blood circulation o - Muscle re-education o - Maintaining or increasing range of motion o - Immediate postsurgical stimulation of calf muscles to prevent venous 0 thrombosis. - TENS for: ● - Symptomatic relief of chronic, intractable pain. o - o Management of pain associated with post-traumatic or post-operative conditions.
    Device Description
    The Tone-A-Matic is a Tone-A-Matic Device is Non-TRANSIT-OPERABLE and PORTABLE micro-controller operated device not to be Worn by patient. It generates electrical impulses and effectively transfers your desired choice of these pre-programmed electrical impulses directly through the electrode adhesive pads to the suggested area of the body where the electrodes are placed. Tone-A-Matic was developed based on physics, electro biology and modern micro-electronic technology. You will be more than pleased with this state-of-the-art device. The Tone-A-Matic is very user friendly with a large liguid crystal display (LCD) screen that displays the treatment mode in use, a countdown timer and battery indicator. The intensity of the treatment can be increased or decreased by Keypads. User can set the time of the treatment from available choice of 1 min. to 60 min. It is a clinical model with easy user interface and versatility to treat different body areas simultaneously. This aesthetically designed clinical model has 3 selectable modes(Russian, TENS, EMS) and treatment parameters. The state of the art Tone-A-Matic is light weight (1.78 Kg), small in size (10.3" X 7.5" X 3.5", LxWxH) and battery powered which allows it to be easily moved to any location for immediate use.
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