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510(k) Data Aggregation

    K Number
    K040554
    Device Name
    ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM71256
    Manufacturer
    MANUFACTURING TECHNOLOGY, INC.
    Date Cleared
    2004-07-16

    (136 days)

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

    MANUFACTURING TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Actigraph is a small, limb-worn activity monitor, typically placed on the wrist or ankle, designed for documenting physical movement associated with applications in physiological monitoring. The device is intended to monitor limb activity associated with movement during sleep. The Actigraph can be used to assess activity in any instance where quantifiable analysis of physical motion is desirable.
    Device Description
    The ActiGraph is a compact wrist, waist, or ankle worn, battery-operated activity monitor whose physical characteristics are similar to a wristwatch. The monitor consists of the activity monitor itself and a disposable wrist strap, belt clip, or nylon pouch. The ActiGraph is intended for the measurement, storage, and analysis of body activity. The ActiGraph can be attached to the subject's limb or torso, and through the use of an accelerometer, motion measured, the activity stored within the activity monitor. A computer program is used to set up the ActiGraph to collect data. This program is called Actisoft and runs on an IBM-compatible personal computer (PC) having a WINDOWS OS. The major functions of Actisoft are to program the device to collect data, retrieve the data from the activity monitor, display the data, and rename and store the data for storage for future reference and comparison. The ActiGraph's Reader Interface Unit is a compact interface device that provides a communications link between the ActiGraph and the PC. The ActiGraph Reader is connected to the serial communications port of the PC via a standard 9-conductor RS-232 cable or an USB adapter. The ActiGraph utilizes a motion sensor known as an "accelerometer" to monitor the occurrence and degree of motion. This type of sensor integrates the amplitude and speed of motion and produces a small signal whose magnitude and duration depend on the amount of motion. The activity signals are amplified, filtered, and digitized by the on-board electronics. This information is stored in memory on board the device as activity counts.
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