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510(k) Data Aggregation

    K Number
    K092990
    Device Name
    AMD 6605 TENS/NMES
    Manufacturer
    ADVANTAGEOUS MEDICAL DEVICES, LLC
    Date Cleared
    2009-10-23

    (25 days)

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

    ADVANTAGEOUS MEDICAL DEVICES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TENS: • Symptomatic relief and management of chronic (long-term), intractable pain and an adjunctive treatment in the management of post-surgical pain and post-traumatic acute pain NMES: - Relaxation of muscle spasms - · Prevention or retardation of disuse atrophy - · Increasing local blood circulation - Muscle re-education - · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis · Maintaining or increasing range of motion
    Device Description
    The AMD 6605 is a 2 channel TENS/NMES stimulator device that is used to help reduce pain, with each channel being isolated from the other. The AMD 6605 is a programmable device that come equipped with 10 preset programs along with 10 user programs. The user programs are adjustable and can be changed to best help the patient at the doctor's recommendation and prescription settings. The program modes are preset programs that a clinician can conveniently choose from should they desire. This device has a special masking program to make the unwanted programs unavailable to the patients while locking the device in the needed relief setting. This way the patient does not receive the knowledge or ability to change the doctor's prescription settings without a clinician's consent. The AMD 6605 is programmed to default to program P-10 which contains the most common setting. The device gives the clinician ability to store frequencies or to choose from a set of many frequencies that allow quick and easy selection, for prescription of stimulation regimen that can be later stored in any of the many available memory slots. However once the program is set the patients does not have the ability to alter the program from what the doctor or licensed practitioner has deemed to be the most appropriate program for their patient's needs. The AMD 6605 has the following specifications: There is pulse mode with a bi-phase retangular pulse, the pulse frequency is 1 Hz to 3.65KHz, the pulse width is 30us, and the pulse amplitude is 140 levels(less than 70mA peak into 1000 ohms load to each channel). The power supply of AMD 6605 is 6.0V DC; this is supplied by four AAA type batteries.
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