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510(k) Data Aggregation

    K Number
    K052934
    Device Name
    DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM
    Date Cleared
    2006-06-12

    (236 days)

    Product Code
    Regulation Number
    890.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    S.O.R. INTERNACIONAL, S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The indications for use include the following: a. Therapeutic Massager: Provides temporary relief of minor muscle aches and pains; Relieves muscle spasms; Temporarily improves local blood circulation; Temporarily reduces the appearance of cellulite. b. Ultrasonic Diathermy: Relief of pain; Muscle spasms; Joint contractures; NOT for the treatment of malignancies.
    Device Description
    The Dermosonic unit is housed in an injected plastic cabinet. Control panels at the top of the cabinet incorporate all the elements required to operate the unit and control and view the various treatment parameters. Below the control panels are spaces to hold the various accessories. There are wheels at the bottom so the device can be easily moved from place to place. Technical specifications for primary components of the devices are: 1. Therapeutic Massager: The device incorporates a motor powered vacuum suction modality with a maximum suction power of 820 milli-bars (mbar). The airflow is rated at 3.500 liters per hour. The device has two suction modes: Continuous and Pulsed. In the Continuous Mode, the suction is constant. In the Pulsed Mode, the suction is intermittent. The suction therapy is delivered to the body with three different size application heads to treat different parts of the body which utilize stainless steel ball bearings to allow the heads to be easily moved over the body. The head are moved over the body in different patterns and directions to achieve varying treatment objectives. 2. Ultrasonic diathermy (US-6000): The device utilizes a 3 MHz ultrasound head. The applicator crystal is made of AL 6063 (a special type of aluminum commonly used in heat sink material and in CPU cooling fans). Ultrasonic energy can be emitted continuously or intermittently with pulses of limited duration. In the pulse mode, the duration of the pulse (or pulse time) varies from 0.5 milliseconds (msec) to 2 msec. The device allows the operator to select any one of four available ultrasonic emission modes.
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