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510(k) Data Aggregation

    K Number
    K132764
    Device Name
    MOTION WATCH AND PRO-DIARY
    Manufacturer
    CAMNTECH, LTD
    Date Cleared
    2014-01-21

    (139 days)

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

    CAMNTECH, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MotionWatch and PRO-Diary are compact, lightweight, body-worn activity monitoring devices that may be used to document physical movement associated with applications in physiological monitoring. The devices are intended to monitor limb or body movements during daily living and sleep. The MotionWatch and PRO-Diary can be used to assess activity in any instance where quantifiable analysis of physical motion is desired. Additionally, the PRO-Diary has a built-in score pad that allows the wearer to subjectively assign and enter responses to pre-programmed questions. The score pad can be used as a substitute or in addition to the traditional written patient diary in conjunction with activity monitoring.
    Device Description
    MotionWatch and PRO-Diary are compact, ambulatory, battery-operated activity recorders with physical characteristics similar to a small wristwatch. The MotionWatch and PRO-Diary are intended for the acquisition and analysis of the physical activity of the body during daily living and sleep. The MotionWatch and PRO-Diary use state of the art miniature accelerometer technology to measure movements of the limb or torso and store these data within the devices differ in that the MotionWatch incorporates an ambient light sensor whereby the PRO-Diary incorporates a display and score-pad to allow subjective inputs. The MotionWatch and PRO-Diary require operational software to allow configuration. data download, storage and off-line analysis of activity data by a health, care provider. The software can be run on an IBM-Compatible PC and the device is connected directly by means of a standard Universal Serial Bus connection for configuration and download. The MotionWatch and PRO-Diary utilize a motion sensor known as an "accelerometer" to measure the occurrence and degree of motion. The sensor is a solid state device with a digital output directly proportional to physical acceleration in 1, 2 or 3 axes of orientation. The acceleration data are processed into "counts" before being stored in the non-volatile memory of the device.
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    K Number
    K100266
    Device Name
    ACTIWAVE 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, ACTIWAVE CARDIO MODEL 08-514, 08-521, 08-536, 08-557, 08-603
    Manufacturer
    CAMNTECH, LTD
    Date Cleared
    2010-04-29

    (90 days)

    Product Code
    MWJ
    Regulation Number
    870.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAMNTECH, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Actiwave Recorder is an ambulatory, body-worn, dermally-affixed, physiological signal and activity recorder. Actiwave is indicated for use in recording physiological waveforms and activity as part of a physiological recording system. The subject is not restricted to a medical environment. The subject may participate in normal activities while the Actiwave recorder is in place. Actiwave is a multi-use recorder. Actiwave may be used wherever quantifiable measurement of human physiological signal waveforms and/or activity are needed. Actiwave may be used in a clinical setting or in basic scientific research under the supervision of a trained clinician.
    Device Description
    Activave is a compact, ambulatory, battery-operated physiological signal recorder. Actiwave is commonly known as an Ambulatory Electrocardiograph. Because of its small size and battery operation, Actiwave may be used in a clinical or non-clinical setting to record physiological signal waveforms while the patient is unattended. The device obtains its signal from the skin surface through the use of standard gel-type signal electrodes. Actiwave may be worn during daily activities and is fully ambulatory due to its small size and its battery-operated power source. Recorded data may be transferred later to a personal computer for storage and archiving. Actiwave does not provide any data viewing or data analysis functions.
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