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The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia, and dyskinesia. It includes a medication reminder, an event marker and is intended to monitor activity associated with movement during sleep. The device is indicated for use in individuals 46 to 83 years of age.

The Personal Kinetigraph (PKG) Gen 2 Plus utilizes a PKG Watch (movement data logger) worn by the patient on their wrist over 6-to-10 day recording cycles. The PKG Watch continuously records and quantifies the kinematics of movement disorder symptoms such as bradykinesia (BK), dyskinesia (DK), tremor, immobility, and dyskinesia fluctuations, in movement disorder conditions such as Parkinson's disease. Proprietary PKG Analysis Algorithms are used to analyze the movement data and generate a PKG-2A Report, which provides the clinical provider with a summary of these movement disorder symptoms, plotted over the full recording period. The PKG-2A Report includes an additional feature that allows the plots to be annotated by a qualified PKG Reporter. The PKG Watch includes a medication reminder to notify the patient when it is time to take their medication, and an event marker for the patient to record when they have taken their prescribed medication. The Personal Kinetigraph (PKG) Gen 2 Plus System includes the GKCM Cloud Platform (PKG Clinic Server), a cloud-based service for receiving and processing the movement data files and generating PKG-2A Reports. The Personal Kinetigraph (PKG) Gen 2 Plus is a modified version of the predicate Personal Kinetigraph (PKG) System Model GKC-2000 (Gen 2) cleared under K161717, incorporating several new or enhanced features, including a Docking Station for charging the PKG Watch and uploading movement data files to the GKCM Cloud Platform, and a Clinic Portal (housed in the GKCM Cloud Platform), providing customer facing functions such as creating and editing patient details, scheduling medication reminders, raising PKG orders and viewing the PKG-2A Report. The Personal Kinetigraph (PKG) Gen 2 Plus also includes a PKG Tablet and PKG Dock Cable, cleared previously under K161717. The PKG Tablet is an off-the-shelf Android based tablet that runs a custom software application to configure the PKG Watch before a recording session, extract recorded data after a recording session, and upload this data to the GKCM Cloud Platform. The PKG Dock Cable connects the PKG Watch to the PKG Tablet for configuration before a recording session, and allows for uploading of the movement data to the PKG Clinic Server after the recording session. The PKG Tablet and PKG Dock Cable are not required when using the Docking Station and Clinic Portal. The Personal Kinetigraph (PKG) Gen 2 Plus system consists of the following key components: PKG Watch (movement data logger) including wrist bands; PKG Docking Station; PKG Clinic Portal; GKCM Cloud Platform (PKG Clinic Server); PKG Analysis Algorithms; PKG-2A Report; PKG Tablet; PKG Dock Cable; and 5-Bay charger.

The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia and dyskinesia. It includes a medication reminder, an event marker and is intended to monitor activity associated with movement during sleep. The device is indicated for use in individuals 46 to 83 years of age.

The new Personal Kinetigraph (PKG) System, Model GKC-2000 (Gen 2), utilizes a small, wrist-worn data logging activity monitor (the PKG Watch) that continuously records and quantifies the kinematics of movement disorder symptoms over a 6 to 10 day period in movement disorder conditions such as Parkinson's disease. At the end of the recording period, the movement recording data is uploaded via a Tablet application at the supervising clinic, to a cloud-based server. A report is produced using the recorded data that objectively distinguishes the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility. This information can be used by the clinician to assess the extent and severity of movement disorder symptoms, and how they vary throughout the day, and from day to day. The PKG Watch has a medication reminder to the patient that it is time to take their medication, and an event marker for the patient to record when they have taken their prescribed medication.

The Personal Kinetigraph (PKG) System is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia. It includes a medication reminder, an event marker and is intended to monitor associated with movement during sleep. The device is indicated for use in individuals 46 to 83 years of age.

The Personal Kinetigraph (PKG) System is a small, wrist-worn activity monitor that continuously records and quantifies the kinematics of movement disorder symptoms over a 6 to 10 day period in movement disorder conditions such as Parkinson's disease. A report is produced using the recorded data that objectively distinguishes the movement patterns consistent with tremor, bradykinesia, and immobility. This information can be used by the clinician to assess the extent and severity of movement disorder symptoms, and how they very throughout the day, and from day to day. The PKG Data Logger has a medication reminder to indicate to the patient that it is time to take their medication, and an event marker for the patient to record when they have taken their prescribed medication.