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510(k) Data Aggregation

    K Number
    K063728
    Device Name
    TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM
    Manufacturer
    ALFA TECH MEDICAL SYSTEMS, LTD.
    Date Cleared
    2007-04-04

    (110 days)

    Product Code
    IMG, IMI, IPF, ISA, LIH
    Regulation Number
    890.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALFA TECH MEDICAL SYSTEMS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Therapeutic Ultrasound: 1. Pain relief 2. Reduction of muscle spasm 3. Localized increase of blood flow 4. Increase range of motion of contracted joints using heat and stretch techniques Neuromuscular Stimulation: 1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute surgical pain 2. Temporary relaxation of muscle spasm 3. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles 4. Increase of blood flow in the treatment area. 5. Prevention or retardation of disuse atrophy in post-injury type conditions 6. Muscle re-education 7. Maintaining or increasing range of motion Therapeutic Massager: 1. Relieves muscle spasms 2. Provides temporary relief of minor muscle aches and pains 3. Temporarily improves local blood circulation 4. Temporarily reduces the appearance of cellulite
    Device Description
    The TNN-DU810 Non-Invasive Subdermal Therapy System is comprised of the following main components: A system console including software and control electrodes; A control and display panel: . Device accessories including muscle stimulator electrodes (ME2221, Mettler Corp., K#013192) and cables, ultrasound transducers (applicators) (ME7513, Mettler Corp.) acoustic gel (Sonigel, Mettler Corp), and cables. The electrodes. ultrasound transducers and acoustic gel have all been cleared under the Mettler Electronics Corp. 510(k). Also included is a Dermosonic vacuum treatment roller head, cleared under the Dermosonic device. K024307. The TNN-DU810 device has dual frequencies ultrasound therapy, muscle stimulator systems and therapeutic vacuum massager. The user friendly interface comprises keyboard, touch screen and audio feedback. The screen provides operator information about operation mode and signal intersities. Large control knobs on the touch screen make adjusting power for ultrasound and muscle stimulation. The system consists of the Alfatech DU857 device (K#052340) and the Dermosonic Therapeutic Vacuum Applicator, a component cleared in the Dermosonic K#024307 .. The frequency Ultrasound Therapy, Muscle Stimulator System is identical to the DU857. It is important to note that there is no electric connection between the ultrasound therapy, muscle stimulator system and the therapeutic vacuum massager. Each of the two components of the system (ultrasound plus neuromuscular stimulation) and the therapeutic massager function independently and have no connection between them.
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    K Number
    K052340
    Device Name
    DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR SYSTEM
    Manufacturer
    ALFA TECH MEDICAL SYSTEMS, LTD.
    Date Cleared
    2005-12-09

    (105 days)

    Product Code
    IMG, IMI, IPF, LIH
    Regulation Number
    890.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALFA TECH MEDICAL SYSTEMS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Therapeutic Ultrasound: 1. Pain relief 2. Reduction of muscle spasm 3. Localized increase of blood flow 4. Increase range of motion of contracted joints using heat and stretch techniques. Neuromuscular Stimulation: 1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute surgical pain 2. Temporary relaxation of muscle spasm 3. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles 4. Increase of blood flow in the treatment area. 5. Prevention or retardation of disuse atrophy in post-injury type conditions 6. Muscle re-education 7. Maintaining or increasing range of motion
    Device Description
    The DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator System is comprised of the following main components: · A system console including software and control electronics; · A control and display panel; · Device accessories including Muscle Stimulator electrodes (ME2221, Mettler Com.), ultrasound applicators (ME7513, Mettler Corp.), acoustic gel (Sonigel, Mettler Corp.) and cables, supplied by Alpha Tech. The DU857 is a two-channel unit for therapeutic ultrasound and muscle stimulation folded into a specially designed cart. The microprocessor controlled DU857 provides Muscle Stimulator alternating current with enhanced reliability and user friendly interface. The DU857 offers 1 and 3 MHz ultrasound treatment. The user friendly interface comprises keyboard, touch screen and audio feedback. The screen provides operator information about operation mode and signal intensities. Large control soft knobs on the touch screen make easy adjusting of power for ultrasound and muscle stimulation.
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