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510(k) Data Aggregation

    K Number
    K063447
    Device Name
    INSIGHT DISCOVERY
    Manufacturer
    FASSTECH
    Date Cleared
    2007-08-16

    (274 days)

    Product Code
    IKN, HCC, REG
    Regulation Number
    890.1375
    Why did this record match?
    Applicant Name (Manufacturer) :

    FASSTECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To measure bilateral differences in surface EMG along the spine To measure surface EMG along the spine during functional tasks To measure bilateral differences in skin temperature along the spine To measure Range of Motion of the three spinal regions To measure patient self-reported pressure sensitivity in joints and muscles To measure Heart Rate To chart patient progress during the course of treatment
    Device Description
    The Insight Discovery is a non-invasive, multi-modality physiologic monitoring device. The Insight Discovery contains the following six sensor types: (1) surface EMG used to measure muscle activity, (2) infrared temperature sensor used to measure skin temperature, (3) algometer used to measure patient self-reported pressure sensitivity, and (4) heart rate sensor to measure heart rate, (5) an inclinometer used to measure end-point range of motion, and (6) a wireless version of the inclinometer.
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    K Number
    K033452
    Device Name
    CWAS 1000
    Manufacturer
    FASSTECH
    Date Cleared
    2003-11-28

    (29 days)

    Product Code
    IKN
    Regulation Number
    890.1375
    Why did this record match?
    Applicant Name (Manufacturer) :

    FASSTECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CWAS 100 is a non-invasive, multi-modality physiologic monitoring device. The device measures several physiologic signals, and its software generates a report. The CWAS 100 measures the following physiologic signals: - Bilateral differences in surface EMG along the spine - Heart Rate - Skin temperature - Galvanic Skin Resistance - Body fat percentage in subjects eighteen years and older
    Device Description
    The CWAS 100 is a non-invasive, multi-modality physiologic monitoring device. The CWAS 100 contains the following five sensor types: (1) surface EMG, (2) IR Plethsmograph, (3), Skin temperature, (4) Galvanic Skin Resistance and (5) IR Body Composition Analyzer. Hardware: The CWAS 100 hardware consists of an instrument console and five different sensor types. All five sensor types plug directly into the front panel of the CWAS 100 Instrument Console. The CWAS 100 Console is powered via a UL2601 listed power supply. The Instrument Console is connected to a personal computer (IBM compatible) via an isolated USB port connection. Software: The CWAS 100 software displays real-time surface EMG, heart rate, skin temperature, Galvanic Skin Resistance, and Body Composition, allowing the user to ensure that readings are stable prior to data collection. The CWAS 100 software allows the user to: (1) enter patient information, (2) record surface EMG, heart rate, skin temperature, Galvanic Skin Resistance, and Body Composition, and (3) print out a data report which summarizes the results of the above sensors as well as blood pressure, vital lung capacity, and chest, leg and back strength, which are data provided by the user.
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    K Number
    K023209
    Device Name
    INSIGHT MILLENNIUM III
    Manufacturer
    FASSTECH
    Date Cleared
    2003-10-10

    (379 days)

    Product Code
    IKN, HCC
    Regulation Number
    890.1375
    Why did this record match?
    Applicant Name (Manufacturer) :

    FASSTECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - To measure bilateral differences in surface EMG along the spine - To measure surface EMG along the spine during functional tasks - To measure bilateral differences in skin temperature along the spine - To measure Range of Motion of the three spinal regions - To measure patient self-reported pressure sensitivity in joints and muscles - To measure Heart Rate - To chart patient progress during the course of treatment
    Device Description
    The Insight Millennium III is a non-invasive, multi-modality physiologic monitoring device. The Insight Millennium III contains the following five sensor types: (1) surface EMG used to measure muscle activity, (2) infrared temperature sensor used to measure skin temperature, (3) inclinometer used to measure end-point range of motion, (4) algometer used to measure patient self-reported pressure sensitivity, and (5) heart rate sensor to measure heart rate.
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    K Number
    K011964
    Device Name
    INSIGHT MILLENNIUM PLUS
    Manufacturer
    FASSTECH
    Date Cleared
    2001-09-20

    (87 days)

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

    FASSTECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To measure bilateral differences in surface EMG along the spine To measure surface EMG along the spine during functional tasks To measure bilateral differences in skin temperature along the spine To measure Range of Motion of the three spinal regions. To measure patient self-reported pressure sensitivity in joints and muscles To chart patient progress during the course of treatment
    Device Description
    The Insight Millennium Plus is a non-invasive, multi-modality physiologic monitoring device. The Insight Millennium Plus contains the following four sensor types: (1) surface EMG used to measure muscle activity, (2) infrared temperature sensor used to measure skin temperature, (3) inclinometer used to measure end-point range of motion, and (4) algometer used to measure patient self-reported pressure sensitivity.
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    K Number
    K011983
    Device Name
    INSIGHT GENESIS
    Manufacturer
    FASSTECH
    Date Cleared
    2001-08-30

    (65 days)

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

    FASSTECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To measure bilateral differences in surface EMG along the spine To measure surface EMG along the spine during functional tasks To chart patient progress during the course of treatment
    Device Description
    The Insight Genesis is a non-invasive, single-modality physiologic monitoring device. The Insight Genesis contains two surface EMG sensors used to measure muscle activity. Hardware: The Insight Genesis hardware consists of an instrument console and two surface EMG sensors. The Insight Genesis will plug directly into the UL-2601 listed wall mounted power supply. The Instrument Console is powered by a computer (IBM compatible) via an isolated serial port connection. Software: The Insight Genesis software displays real-time surface EMG, allowing the user to ensure that readings are stable prior to data collection. The Insight Genesis software allows the user to: (1) collect and store surface EMG, (2) view and analyze surface EMG, and (3) print out reports.
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    K Number
    K990778
    Device Name
    INSIGHT MILLENNIUM
    Manufacturer
    FASSTECH
    Date Cleared
    1999-06-03

    (86 days)

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

    FASSTECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - To measure bilateral differences in surface EMG along the spine . - To measure surface EMG along the spine during functional tasks . - To measure bilateral differences in skin temperature along the spine . - . To measure Range of Motion of the three spinal regions - . To chart patient progress during the course of treatment
    Device Description
    Not Found
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    K Number
    K961212
    Device Name
    SPINAL TOUCH
    Manufacturer
    FASSTECH
    Date Cleared
    1996-06-12

    (76 days)

    Product Code
    KQX
    Regulation Number
    888.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    FASSTECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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