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510(k) Data Aggregation

    K Number
    K010837
    Device Name
    HANDMASTER
    Manufacturer
    NEUROMUSCLAR ELECTRICAL STIMULATION SYSTEMS, LTD.
    Date Cleared
    2001-06-15

    (87 days)

    Product Code
    GZI, IPF, IRO
    Regulation Number
    882.5810
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEUROMUSCLAR ELECTRICAL STIMULATION SYSTEMS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K952273
    Device Name
    HANDMASTER NMS1
    Manufacturer
    NEUROMUSCLAR ELECTRICAL STIMULATION SYSTEMS, LTD.
    Date Cleared
    1996-05-23

    (374 days)

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

    NEUROMUSCLAR ELECTRICAL STIMULATION SYSTEMS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The N.E.S.S. HANDMASTER NMS1 is intended to be used to exercise the lower arm and hand by activating the muscles thereof with electrical stimulation. As a powered muscle stimulator, the HANDMASTER NMS1 is intended to be used for the following indications: Maintenance or increase of range of motion, reduction of spasticity, prevention or retardation of disuse atrophy, facilitation and re-education of voluntary motor function, and influencing local blood circulation.
    Device Description
    The HANDMASTER NMS1 is a portable, one-channel electrical neuromuscular stimulator for personal use in exercising the upper extremity. The stimulator serves five surface electrodes held on to the upper limb by a splint. The control unit housing the stimulator may be worn using the shoulder strap provided, or it may be placed on any stable surface. The splint is worn on the hand and forearm. The splint is connected to the control unit by a light cable. The HANDMASTER NMS1 is used for exercising the hand, conditioning selected muscles of the forearm and hand. It is intended for use by patients suffering from upper limb paralysis due to injury or disease of the central nervous system such as cervical spinal cord injuries or stroke. A single channel of constant-voltage symmetrical biphasic Russian waveform stimulation is delivered to the muscles through five surface electrodes. Microprocessor-controlled switching of the stimulation between these five electrodes allows the muscles to be activated in combinations either cyclically or continuously. The stimulation is ramped up at the beginning and down at the end of each cycle. The electrode locations allow the HANDMASTER NMS1 to give finger and thumb extension and flexion. The user can select from five stimulation programs by pressing the mode button on the control unit. The active mode is displayed by a light glowing next to the labeled mode. When the device is stimulating, the light flashes. The stimulation programs are supplied as microprocessor firmware. They comprise either cyclic or continuous activation of the finger and thumb extensors and flexors. The user can increase or decrease the stimulation intensity in ten discrete levels by pressing on buttons labeled "+" or "-" on the control unit. This alters the duration of the stimulation pulse. The intensity is displayed as a number (0 to 9) on a seven-segment display. During the initial system set-up, the clinician opens a clinical panel within the control unit. Adjustments are provided for limiting the maximum current to the extensor muscles and to the flexor muscles, along with a global timing factor which increases or decreases the duration of the stimulation cycles, effectively speeding or slowing the cyclic hand motion. The user starts or stops the stimulation program by pressing a "trigger" button. If required, the user may also stop all stimulation immediately by switching OFF the device. The HANDMASTER NMS1 splint is used to hold the wrist joint at a comfortable extension angle (20°), and also to hold the electrodes on the forearm and hand segments. It is constructed from fiber-reinforced plastic with soft polyurethane cushion sections to distribute stress over bony regions. The electrodes are made from metal foil coated with carbon-impregnated polymer. Replaceable water-soaked cloth pads are arranged over the electrodes to provide a conductive interface with the skin. A sponge-capped bottle is provided to facilitate wetting of the electrode pads. Rechargeable nickel-cadmium batteries power the device. Battery status can be displayed both during device operation and while recharging the Sources. Both visual and audio battery-low warnings are provided. It is necessary to disconnect splintelectrodes in order to recharge the batteries, as the same socket is used for both.
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