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510(k) Data Aggregation

    K Number
    K221958
    Device Name
    Flex-MI
    Manufacturer
    EMSI, Inc.
    Date Cleared
    2022-10-21

    (108 days)

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

    EMSI, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Interferential Stimulation - > Symptomatic relief of chronic intractable pain - > Adjunctive treatment for the management of post-traumatic or post-surgical pain EMS (Electrical Muscle Stimulation) - > Relaxation of muscle spasm - > Increasing local blood circulation - > Muscle re-education - > Prevention or retardation of disuse atrophy - > Prevention of venous thrombosis of the calf muscles immediately after surgery - > Maintaining or increase range of motion
    Device Description
    The Flex-MI is a combination EMS and interferential stimulation device which delivers nerve or muscle stimulation by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the intended treatment of patient. The stimulator has 2 output channels, accessed through jacks at the top of the housing, so that it may stimulate either 2 or 4 patient electrodes. The device is powered by 4.8V Ni- MH rechargeable battery pack. A patient compliance timer can memorize 60 sets of operation records; the total recordable time is 999 hours. Flex-MI is compatible and recommended for use with Everlife self-adhesive electrodes (K012463).
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    K Number
    K140467
    Device Name
    FLEX-MT +
    Manufacturer
    EMSI
    Date Cleared
    2014-10-07

    (225 days)

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

    EMSI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    As prescribed by a physician for the following: TENS- Transcutaneous Nerve Stimulation - Symptomatic relief of chronic intractable pain . - . Post traumatic and post surgical pain relief EMS- Electrical Muscle Stimulation - . Relaxation of muscle spasm - . Increasing local blood circulation - . Muscle re-education - . Prevention or retardation of disuse atrophy - Prevention of venous thrombosis of the calf muscles immediately after surgery - . Maintaining or increase range of motion
    Device Description
    The Flex-MT + is a combination TENS and EMS device which delivers nerve or muscle stimulation by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the intended treatment of patient. The stimulator has 2 output channels, accessed through jacks at the top of the housing, so that it may stimulate either 2 or 4 patient electrodes. The device is powered by 700 mAh 4.8V Ni MH rechargeable battery pack. A patient compliance timer can memorize 60 sets of operation records; the total recordable time is 999 hours.
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    K Number
    K102202
    Device Name
    GS 3000
    Manufacturer
    EMSI
    Date Cleared
    2010-11-23

    (111 days)

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

    EMSI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    As prescribed by a physician for the following: Relaxation of muscle spasm Increasing local blood circulation Maintaining or increasing range of motion Preventing or retarding disuse atrophy Muscle re-education Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
    Device Description
    The GS 3000 is a High Voltage Pulsed Galvanic Current (HVPGC) Stimulator which delivers stimulation by applying an electrical current to electrodes, which are attached on the patient's skin. The device has a twin peak monophasic waveform with a 5 usec fixed duration. The current Amplitude is adjustable from 0-350 Volts (0~190V Max @ 500ohm resistance), with an adjustable pulse frequency range from 2-100 cycles per second. The GS 3000 is a single channel device, with the option to set the active electrodes (treatment electrode) to either positive or negative polarity in relation to the dispersive electrode (closes patient circuit) and alternating or synchronous treatment mode selection. The device is powered by a 9 volt battery.
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    K Number
    K090889
    Device Name
    EMSI GARMENT ELECTRODES
    Manufacturer
    EMSI
    Date Cleared
    2009-12-04

    (248 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    EMSI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Electrodes intended for use as reusable (by a single patient), cutaneous, flexible, conductive garment/fabric electrodes for interface between electrical stimulators such as interferential devices, galvanic devices, TENS, etc. and a patient's skin for the delivery of electrical stimulation.
    Device Description
    The EMSI Garment Electrodes are a cloth type device weft knitted of a continuous fiber made up of 77% Nylon and 23% Silver. Each device is flexible, and is available in a range of sizes to ensure good patient contact. A male snap connector is placed within the fabric weave and is connected via the female snap connector to a short lead wire, The lead wire has a female pin connection at the distal end which accepts the lead wire connection from the stimulator. The entire fabric is made up of conductive material to provide uniform current distribution when connected to a stimulator.
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    K Number
    K090717
    Device Name
    FLEX-TENS
    Manufacturer
    EMSI
    Date Cleared
    2009-05-08

    (51 days)

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

    EMSI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K083030
    Device Name
    TENS-EMS-14
    Manufacturer
    EMSI
    Date Cleared
    2009-02-05

    (118 days)

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

    EMSI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TENS- Transcutaneous Nerve Stimulation - . Symptomatic relief of chronic intractable pain - Post traumatic and post surgical pain relief . EMS- Electrical Muscle Stimulation - . Relaxation of muscle spasm - . Increasing local blood circulation - . Muscle re-education - . Prevention or retardation of disuse atrophy - . Prevention of venous thrombosis of the calf muscles immediately after surgery - . Maintaining or increase range of motion
    Device Description
    The TENS-EMS-14 is a combination TENS and EMS device which delivers nerve or muscle stimulation by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the intended treatment of patient. The stimulator has 2 output channels, accessed through jacks at the top of the housing, so that it may stimulate either 2 or 4 patient electrodes. The device is powered by 4 AA batteries. A patient compliance timer can memorize 60 sets of operation records; the total recordable time is 999 hours.
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    K Number
    K071869
    Device Name
    TENS/IF 14
    Manufacturer
    EMSI
    Date Cleared
    2008-03-07

    (245 days)

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

    EMSI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Symptomatic relief of chronic intractable pain Adjunctive treatment for the management of post-traumatic or post-surgical pain
    Device Description
    The TENS/IF 14 is a combination TENS and Interferential device which delivers nerve stimulation by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the intended treatment of patient. The stimulator has 2 output channels, accessed through jacks at the top of the housing, so that it may stimulate either 2 or 4 patient electrodes. The device may be powered by either 4 AA batteries or by an AC adapter, that when plugged into a wall outlet provides 6 VDC to the unit. A patient compliance timer can memorize 60 sets of operation records; the total record time is 999 hours.
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