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510(k) Data Aggregation

    K Number
    K981844
    Device Name
    SLEEP MANAGEMENT SYSTEM
    Manufacturer
    Date Cleared
    1998-08-07

    (73 days)

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

    RMP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To provide sleep assessment. For instance, the device can assess current sleep habits by measuring sleep latency and total sleep time.
    Device Description
    The Sleep Management System consists of a slender plastic case with front and back faces and a plastic strap. The user wears the strap around his wrist so that the device will not drop to the floor when the user falls asleep. On the front face, the device has a display, three function buttons, and two electrodes. On the back face, the device has a thumb-activated switch. The display shows either minutes and hours awake or asleep. Two of the three function buttons cause either time awake or time asleep to be displayed and the third function button is the stop/reset button. The two electrodes are located in a recessed section of the front face. The two electrodes form two ends of a circuit. The circuit is completed by placing fingers across the electrodes. The current in the circuit flows through the user's fingers to pass from one electrode to the other electrode. The switch on the back face of the case and the circuit formed between the two electrodes operate the timing function of the device. The circuitry of the device includes a 1.5 volt watch battery, power supply, clock, alarm, light, memory, delay and a control and routing circuit. The power supply powers the device using the battery's stored energy. The clock times the user's time awake and time asleep. By pressing the various function buttons, the device will display the time awake or asleep. The memory stores the user's time awake and time asleep. The timing functions have a three second delay for switching between functions so that the user can briefly adjust finger positioning without changing modes.
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