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510(k) Data Aggregation

    K Number
    K033534
    Device Name
    VITALSENSE
    Manufacturer
    MINI-MITTER CO., INC.
    Date Cleared
    2004-04-22

    (164 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    MINI-MITTER CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VitalSense® can be used in any setting where physiological body core and skin temperature are used to further the understanding of body function. The device can be used for simultaneous assessment of core body temperature, dermal surface temperature, or ambient temperatures that require logging of data over time with subsequent conversion, display, and analysis of the aforementioned parameters. VitalSense® may be used in any instance where quantifiable analysis of temperature data is desirable.
    Device Description
    VitalSense® is a compact, ambulatory, physiological data logger. VitalSense® may be attached to the belt or worn in a shirt pocket. Up to ten telemetric sensors may be used with a single VitalSense® logger. The device senses and records physiological data and displays the data on its LCD screen. Recorded data may be transferred later to a PC for display and conversion for export to other programs.
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    K Number
    K011430
    Device Name
    ACTIWARE-PLMS
    Manufacturer
    MINI-MITTER CO., INC.
    Date Cleared
    2001-05-31

    (22 days)

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

    MINI-MITTER CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991045
    Device Name
    MINI-LOGGER SERIES 2000
    Manufacturer
    MINI-MITTER CO., INC.
    Date Cleared
    1999-09-21

    (176 days)

    Product Code
    GWK
    Regulation Number
    882.1845
    Why did this record match?
    Applicant Name (Manufacturer) :

    MINI-MITTER CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mini-Logger® Series 2000 (hereafter referred to as Mini-Logger) is a compact, lightweight, physiological data logger for monitoring heart rate, interbeat-interval (IBI), temperature, ambient light, and activity. The Mini-Logger® can be used in behavioral and circadian rhythm studies, sleep research, occupational health and sports medicine research, and obesity/weight loss studies. The device can be used for any assement of human heart rate or IBI, temperature, and activity that requires logging of data over time and an integrated analysis of the forementioned parameters. The Mini-Logger® may be used in any instance where quantifiable analysis of physiological data is desirable.
    Device Description
    The Mini-Logger® Series 2000 is a compact physiological data logger whose physical size and appearance are similar to a small TV remote control. The Mini-Logger® is powered from two replaceable, non-rechargeable lithium cells. The Mini-Logger® is generally worn in the shirt pocket or on a belt using its optional soft pouch. Direct-wired probes used to sense the physiological data are plugged into one or more of the four available data input channels. The device acquires and logs digital data and resistances whose values represent the amplitudes of physiological signals. The physiological signals are temperature, heart inter-beat-interval (IBI), counts representing gross motor activity, and resistance representing ambient light intensity.
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    K Number
    K991033
    Device Name
    ACTIWATCH-SCORE
    Manufacturer
    MINI-MITTER CO., INC.
    Date Cleared
    1999-06-23

    (86 days)

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

    MINI-MITTER CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Actiwatch-Score® is a compact, lightweight, wrist-worn activity monitor that can be used to analyze circadian rhythms, automatically collect and analyze data for sleep parameters, and assess activity in any instance where quantifiable analysis of physical motion is desirable. In addition, the Actiwatch-Score® has a built-in score pad that allows the subject to subjectively assign and enter a score from 0 to 9. The score pad can be used as a substitute or in addition to the traditional patient diary used in conjunction with activity monitoring.
    Device Description
    The Actiwatch-Score® 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 disposable wrist band. The Actiwatch-Score® is intended for the measurement, storage, and analysis of body activity. The Actiwatch-Score® 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 Actiwatch-Score® to collect data. This program is called Actiware-Sleep and runs on an IBM-compatible personal computer (PC). The major functions of Actiware-Sleep are to create a patient score schedule, 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 Actiwatch® Reader is a compact interface device that provides a communications link between the Actiwatch-Score® and the PC. The Actiwatch® Reader is connected to the serial communications port of the PC via a standard 9-conductor RS-232 cable. The Actiwatch-Score® 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 and digitized by the on-board circuit. This information is stored in memory on board the device as activity counts. In addition, the patient self-score data are stored as integer values within memory.
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    K Number
    K983533
    Device Name
    ACTIWATCH
    Manufacturer
    MINI-MITTER CO., INC.
    Date Cleared
    1999-03-23

    (166 days)

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

    MINI-MITTER CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Actiwatch® is an ultra-compact, lightweight, wrist-worn activity and ambient light monitor that can be used to analyze circadian rhythms, automatically collect and score data for sleep parameters, and assess activity in any instance where quantifiable analysis of physical motion is desirable.
    Device Description
    The Actiwatch® 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 disposable wrist band. The Actiwatch® is intended for the measurement, storage, and analysis of body activity. The Actiwatch® 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 un the Actiwatch® to collect data. This program is called Sleepwatch and runs on an IBM-compatible personal computer (PC). The major functions of Sleepwatch 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 Actiwatch® Reader is a compact interface device that provides a communications link between the Actiwatch® and the PC. The Actiwatch® Reader is connected to the serial communications port of the PC via a standard 9-conductor RS-232 cable. The Actiwatch® 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 and digitized by the on-board circuit. This information is stored in memory on board the device as activity counts.
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