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510(k) Data Aggregation

    K Number
    K231532
    Device Name
    ActiGraph LEAP activity monitor (ActiGraph LEAP)
    Manufacturer
    ActiGraph, LLC
    Date Cleared
    2023-06-23

    (28 days)

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

    ActiGraph, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ActiGraph LEAP™ is a small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring. The device is intended to monitor the activity associated with movement during sleep. The ActiGraph LEAP™ can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.
    Device Description
    The ActiGraph LEAP™ is a wrist-worn wearable device intended to continuously record high resolution digital acceleration data associated with a patient's physical movement. In practice, a healthcare professional or researcher can prescribe the device to collect physiological data from patients in applications where quantifiable analysis of physical motion is desirable. Having physical characteristics like those of an electronic wristwatch, the device is set to collect data by the healthcare professional then placed on the subject's wrist. The device is designed to be worn during normal activities and/or during sleep over a period of days to weeks. The patient does not need to interact with the device to control the operation or data collection. The data stored on the device can be downloaded via USB or Bluetooth Low Energy and made accessible to healthcare professionals or researchers for further analysis. The ActiGraph LEAP™ device will be supported by accessories for recharging the battery and transferring data from the device. A USB Charging Dock with a three-foot USB A cable for both charging and data transfer to a PC using the supplied communication software. The USB Charging Dock connects to the recessed electrical contacts on the back of the device. An off-the-shelf international Wall Mount AC Adapter is also supplied for optional wall charging. The USB Charging Dock can be plugged into the Wall Mount AC Adapter's USB A port for charging the device. The device uses a high-resolution digital accelerometer to accurately measure linear accelerations in 3axes associated with the patient's physical movement. The accelerometer technology is a microelectromechanical system (MEMS) implemented as an integrated circuit. The accelerometer data is converted to a digital representation on the MEMS accelerometer and then recorded, with timestamp, to the device's on-board memory. The memory is an 8 Gb serial NAND flash capable of storing 30 days of accelerometer data under the default operating mode. The sample rate of the accelerometer is configurable at the following rates: 32Hz, 64Hz, 128 Hz and 256Hz. The LCD display indicates the battery level, current functional state of the device, and date and time. The device has a 30-day battery life under the default operating mode and can be charged using the USB Charging Dock accessory. The display does not provide feedback to the wearer/patient regarding data measures. There is a simple button on the side used to turn on the display so the wearer can read the date/time and button presses are recorded in the log. The device firmware executes on internal processors to control the device operations, display, and external communication protocols. The accelerometer sensor data can be downloaded from the device either via USB (using the dock) or via Bluetooth Low Energy.
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    K Number
    K181077
    Device Name
    ActiGraph CentrePoint Insight Watch
    Manufacturer
    ActiGraph
    Date Cleared
    2018-05-24

    (30 days)

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

    ActiGraph

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ActiGraph CentrePoint Insight Watch is a small worn activity monitor designed for document associated with applications in physiological monitoring. The device is intended to monitor the activity associated with movement during sleep. The Insight watch can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.
    Device Description
    The ActiGraph CentrePoint Insight Watch is a compact, battery-operated wearable activity recording device with physical characteristics similar to those of a small wristwatch. The watch is intended to acquire and store data from an onboard accelerometer while being worn during normal activities and/or during sleep. The data record is timestamped and stored in non-volatile memory for later retrieval. Downloaded data can be post-processed based on the timestamp and magnitude of acceleration along each axis. The housing is constructed of a combination of opaque and clear copolyesters formulated specifically for medical devices (i.e., tested and determined biocompatible), and the core data collection sensor is a 3-axis microelectromechanical system (MEMS) accelerometer. A charging dock connected to a USB power source is used to charge the device battery and communicate with a PC or peripheral.
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    K Number
    K080545
    Device Name
    ACTITRAINER
    Manufacturer
    ACTIGRAPH, LLC
    Date Cleared
    2008-07-24

    (148 days)

    Product Code
    ISD
    Regulation Number
    890.5360
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACTIGRAPH, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ActiTrainer is a small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring. The device is intended to monitor the activity associated with movement during sleep. The ActiTrainer can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.
    Device Description
    The ActiTrainer is housed in a polycarbonate plastic housing. It is 8.5 cm long by 3.4 cm wide by 1.6 cm thick and it weights 51 grams. It also has an optional Polar heart strap. Data is downloaded into a PC via a USB plug and the data is displayed with ActiGraph LLC's ActiLife software.
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