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510(k) Data Aggregation

    K Number
    K970051
    Device Name
    MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE
    Date Cleared
    1997-07-10

    (184 days)

    Product Code
    Regulation Number
    882.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    SMITH AND NEPHEW DONJOY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    1) Relaxation Training 2) Muscle Re-education
    Device Description
    The MuscleSense™ II is an EMG (Electromyography) device intended for medical use for muscle re-education and relaxation training. The MuscleSense II, AT , and Pathway MR-25 are all indicated for relaxation training and muscle reeducation. All three devices are used in conjucnction electrodes. The MuscleSense™ II tnresold sensitivity testing confirmed the device to fall within an acceptable sensitivity range to effectively monitor muscle activity. There is no electrical current being delivered to the patient. The device is supplied with pre-gelled conductive electrodes which have been cleared for marketing by the Food and Drug Administration under K851522/A. The device is battery powered or by a UL544 approved wall mounted power supply.
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    K Number
    K963489
    Device Name
    WHEEL CHAIR ACCESSORY
    Date Cleared
    1996-11-12

    (70 days)

    Product Code
    Regulation Number
    880.6760
    Why did this record match?
    Applicant Name (Manufacturer) :

    SMITH AND NEPHEW DONJOY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Safety Poncho, Slider Poncho and the Pelvic Holder are intended for use to assist cooperative patients who require minimum support in wheelchair. The devices are labeled for prescription use and are not intended for lay use.
    Device Description
    These devices are vest and pelvic holder style wheel chair accessories used to assist cooperative patients who require minimum support in a wheelchair. These devices are made of wolyester, cotton, nylon and vinyl configured into either a mesh or weave substrate. Each device utilizes straps for securing (tie) the patient in place.
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    K Number
    K963490
    Device Name
    PROTECTIVE RESTRAINT - BELTS
    Date Cleared
    1996-11-12

    (70 days)

    Product Code
    Regulation Number
    880.6760
    Why did this record match?
    Applicant Name (Manufacturer) :

    SMITH AND NEPHEW DONJOY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    These devices are Universal Gait Belt, Wheelchair Belt, Foam Limb Restraint, Double Buckle Limb Restraint, Comfort Safety Belt, Comfort Slider Belt, Universal Roll Belt and belt style restraints used to restrain patients in a wheelchair or bed. The devices are labeled for prescription use and are not intended for lay use.
    Device Description
    These devices are made of polyester, cotton, nylon and polyethelen configured into either a mesh or weave substrate. Each device utilizes straps for securing (tie) the patient in place.
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    K Number
    K963492
    Device Name
    PROTECTIVE RESTRAINT
    Date Cleared
    1996-11-12

    (70 days)

    Product Code
    Regulation Number
    880.6760
    Why did this record match?
    Applicant Name (Manufacturer) :

    SMITH AND NEPHEW DONJOY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Economy Restraint, Jacket Restraint, Two Piece Vest Restraint, Safety Vest and Hand Control Mitt are incended for use to assist cooperative patients who require minimum support in wheelchair. The devices are labeled for prescription use and are not intended for lay use.
    Device Description
    These devices are vest, jacket and mitt style restraints used to restrain patients in a wheelchair or bed. These devices are made of polyester, cotton, nylon and polyethelen configured into either a mesh or weave substrate. Each device utilizes straps for securing (tie) the patient in place.
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    K Number
    K962462
    Device Name
    MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATOR
    Date Cleared
    1996-09-23

    (90 days)

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

    SMITH AND NEPHEW DONJOY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.
    Device Description
    The MuscleMax™ Plus is a disposable single patient use (Electrical Muscle Stimulator) intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. The output waveform consists of a 2200Hz biphasic, symmetrical one period signal (zero net DC component) in a series of low frequency (72 pps) bursts. Testing confirmed the device to fall within the acceptance criteria of 75uC for maximum charge per pulse when tested with a 500, 2K, and 10K Ohm load and the functional battery life of the device to exceed the minimum specification of 100 hours at maximum intensity. Because the wave is an alternating current, there is no net polar effects to cause long-term positive ion concentrations within the tissues beneath either electrode. The ON/OFF and intensity functions are controlled with a dial into the housing to reduce the potential recessed for inadvertent changes in intensity or accidental turning ON of the device. The unit has a green LED indicating when the unit is ON and releasing an electrical current, and a yellow LED indicating the unit is in the 20 second OFF cycle and will begin to release an electrical current within 20 seconds. The yellow LED warns the user not to increase the intensity until the green LED is illuminated to avoid inadvertent increases in output. The device is supplied with pre-gelled conductive electrode pads which have been cleared for marketing by the Food and Drug Administration under K912461. The electrode leads are strain relieved and designed to remain securely attached to the device (not removable), reducing the potential for attaching to AC power lines. The device is powered by four (4) 1.5 volt DC batteries contained within the housing.
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    K Number
    K955057
    Device Name
    MODEL 1100 COLD THERAPY DEVICE
    Date Cleared
    1996-03-08

    (123 days)

    Product Code
    Regulation Number
    890.5720
    Why did this record match?
    Applicant Name (Manufacturer) :

    SMITH AND NEPHEW DONJOY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The application of ice after surgery or injury to reduce swelling and pain is a well established treatment with well know indications and contraindications.
    Device Description
    The device consists of a tank containing ice and water, a water pump to circulate cold water, a console containing a means to control and indicate temperature and a pad through which the cold water circulates. The purnp, contained in a waterproof case, is submerged in the ice water bath and connected to the console via insulated tubing through which the chilled water flows to and from the pad. The console is located along this tubing about halfway between the pad and the water bath for easy access by the patient. Leakage current for the device shall not exceed 100uA.
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