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510(k) Data Aggregation
K Number
K053214Device Name
THERAKNIT GARMENT ELECTRODE
Manufacturer
NEUROTRON MEDICAL
Date Cleared
2005-12-20
(33 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
NEUROTRON MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TheraKnit Garment Electrodes are cutaneous electrodes to be used with legally marketed TENS and NMES stimulating devices. The knitted garments deliver the stimulation signals generated by the stimulator to the body parts with which they are in contact. These body parts include hands, feet, arms, legs, shoulder, back (pads).
Device Description
The TheraKnit Garment Electrodes are conductive garments knitted from a continuous silver coated Nylon yarn into the form of gloves, socks, sleeves and flat fabric used for pads. The conductivity is derived from the silver content of the Nylon yarn. The garment electrodes are available in a variety of sizes ranging from small to extra large for gloves and small to large for socks and sleeves. The elongation property of the nylon yarn provides some elasticity which ensures firm skin contact. The devices can be used dry or wet when in contact with the skin. The entire surface of each garment electrode is very conductive having a resistance of less than 7 ohms per inch. This low resistance provides low current density with uniform current distribution.
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K Number
K012069Device Name
MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT
Manufacturer
NEUROTRON MEDICAL, INC.
Date Cleared
2001-08-01
(30 days)
Product Code
JXE
Regulation Number
882.1550Why did this record match?
Applicant Name (Manufacturer) :
NEUROTRON MEDICAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BREVIO is intended for use for the measurement of nerve response latency and amplitude in the diagnosis and monitoring of peripheral neuropathies.
The BREVIO is intended to be used as a waveform display nerve conduction monitor. It displays the latency value derived from an action potential. The display shows the latency value in milliseconds from the trigger to the onset. The internal circuitry has the complete waveform from which the latency value is derived and this is delivered to the digital storage oscilloscope for compete waveform display.
The latency value is important in the diagnosis of median nerve dysfunction. The physician can use the BREVIO to examine the features of the waveform generated by the stimuli. The physician can determine the action potential latency, amplitude configuration and duration.
Device Description
The BREVIO is a battery powered (4 AA batteries) hand held device that is utilized to perform motor and sensory nerve conduction testing on peripheral nerves in a clinical setting. It consists primarily of two units, a handheld processor with LCD screen and a stimulator. It may also be coupled with a number of HP inkjet printers to print patient information and results.
The BREVIO automatically picks out the latency and amplitude of waveforms presented to determine the values associated with them. The automatically chosen values may be manually adjusted by the user should the user feel the necessity to manually make such a change.
The BREVIO has memory storage of 28 waveforms for later viewing and printing of the test results.
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K Number
K963208Device Name
NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS)
Manufacturer
NEUROTRON MEDICAL
Date Cleared
1997-07-14
(332 days)
Product Code
JXE, 84J
Regulation Number
882.1550Why did this record match?
Applicant Name (Manufacturer) :
NEUROTRON MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nervepace® ViewScope 200VS is intended to be used as a waveform display nerve conduction monitor. Currently the digital electroneurometer (K843924A ) displays the latency value derived from an action potential. This is accomplished by setting a threshold value into the circuitry and when the onset of the action potential reaches the threshold value it trips the timing circuit and the display shows the latency value in milliseconds from the trigger to the onset. The internal circuitry of the electroneurometer has the complete waveform from which the latency value was derived and this can be delivered to a digital storage oscilloscope for complete waveform display.
The latency value is important in the diagnosis of median nerve dysfunction. The physician can use the ViewScope to examine the features of the waveform generated by the stimulus. The physician can determine the action potential latency, amplitude, configuration and duration.
Device Description
Not Found
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