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510(k) Data Aggregation
K Number
K161717Device Name
Personal Kinetigraph (PKG) System
Manufacturer
GKC MANUFACTURING PTY LTD.
Date Cleared
2016-09-20
(90 days)
Product Code
GYD, ISD, NXQ
Regulation Number
882.1950Why did this record match?
Applicant Name (Manufacturer) :
GKC MANUFACTURING PTY LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
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.
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K Number
K140086Device Name
PERSONAL KINETIGRAPH (PKG) SYSTEM
Manufacturer
GKC MANUFACTURING PTY LTD.
Date Cleared
2014-08-22
(220 days)
Product Code
GYD, ISD, NXQ
Regulation Number
882.1950Why did this record match?
Applicant Name (Manufacturer) :
GKC MANUFACTURING PTY LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
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.
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