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510(k) Data Aggregation
K Number
K982482Device Name
HANDMASTER NMS1
Manufacturer
N.E.S.S. NUROMUSCULAR ELECTRICAL STIMULATION SYST
Date Cleared
1998-09-30
(76 days)
Product Code
IPF
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
N.E.S.S. NUROMUSCULAR ELECTRICAL STIMULATION SYST
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 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 muscle spasm, prevention or retardation of disuse atrophy, muscle reeducation, and increasing 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. 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 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. 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.
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