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510(k) Data Aggregation

    K Number
    K010997
    Device Name
    PAM-RL
    Manufacturer
    INDIVIDUAL MONITORING SYSTEMS, INC.
    Date Cleared
    2001-10-15

    (195 days)

    Product Code
    GWQ, GWO
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    INDIVIDUAL MONITORING SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PAM-RL is a small, limb-worn activity monitor, typically placed on the leg or wrist, designed for documenting physical movements associated with applications in physiological monitoring. The device is intended to monitor limb activity associated with movement during sleep. The unit can also be used to assess activity in any instance where quantifiable analysis of physical motion is desirable.
    Device Description
    The PAM-RL is a compact, limb-worn, battery-operated activity monitor. The monitor consists of the activity monitor itself and a velcro band. The PAM-RL is intended for the measurement, storage, and analysis of limb activity. The PAM-RL can be attached to the subject's limb and through the use of an accelerometer, motion of that limb is measured, the activity is stored within the activity monitor. A computer program is used to set up the PAM-RL to collect data. This program runs on an IBM-compatible personal computer (PC). The major functions of the application software are to program the device to collect data, retrieve the data from the activity monitor, display the data, and to store the data for future reference and comparison. The PAM-RL uses a smart download cable to provide a communiations link between the PAM-RL and the PC. To download data from the PAM-RL to the PC, one end of the PAM-RL's smart cable is inserted into the PAM-RL's port via a miniature 2.5 mm phone plug and the other end connected to the serial communications port of the PC via a standard 9-pin RS-232 COM port. The PAM-RL utilizes a motion sensor known as an accelerometer to monitor the occurrence and degree of motion. This type of sensor provides an analog signal where the amplitude and speed of motion produces a signal whose magnitude and duration depend on the amount of motion. The activity signals are amplified and digitized by the on-board circuit. This information is stored in memory on board the device as activity counts. Activity can alternatively be stored in units of milli-g.
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    K Number
    K992410
    Device Name
    ACTITRAC
    Manufacturer
    INDIVIDUAL MONITORING SYSTEMS, INC.
    Date Cleared
    1999-10-15

    (87 days)

    Product Code
    GWQ
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    INDIVIDUAL MONITORING SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ActiTrac is a small wrist-worn activity monitor designed for documenting physical movements associated with applications in physiological monitoring. The device is intended to be used to analyze circadian rhythms, automatically collect and score data for sleep parameters. These parameters, representing the number and intensity of limb movements, are directly correlated to sleep efficiency. The unit can also be used to assess activity in any instance where quantifiable analysis of physical motion is desirable.
    Device Description
    The ActiTrac is a compact, wrist-worn, battery-operated activity monitor whose physical characteristics are similar to a small wristwatch. The monitor consists of the activity monitor itself and a wrist band. The ActiTrac is intended for the measurement, storage, and analysis of body activity. The ActiTrac can be attached to the subject's limb and through the use of an accelerometer, motion of that limb is measured, the activity stored within the activity monitor. A computer program is used to set up the ActiTrac to collect data. This program runs on an IBM-compatible personal computer (PC). The major functions of the application software are to program the device to collect data, retrieve the data from the activity monitor, display the data, and to store the data for future reference and comparison. The ActiTrac uses a smart download cable to provide a communications link between the ActiTrac and the PC. The ActiTrac utilizes a motion sensor known as an "accelerometer" to monitor the occurrence and degree of motion. This type of sensor provides an analog signal where the amplitude and speed of motion produces a signal whose magnitude and duration depend on the amount of motion. The activity signals are amplified and digitized by the on-board circuit. This information is stored in memory on board the device as activity counts. Activity can alternatively be stored in units of milli-g.
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