{
  "format": "devicerts.device.v1",
  "cite_as": "Personal Kinetigraph (Pkg) System, Gkc Manufacturing Pty Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/personal-kinetigraph-pkg-system-gyd (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/personal-kinetigraph-pkg-system-gyd",
    "json_url": "https://devicerts.com/devices/personal-kinetigraph-pkg-system-gyd.json",
    "markdown_url": "https://devicerts.com/devices/personal-kinetigraph-pkg-system-gyd.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "registry_records_last_synced": "2026-10-22",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/devices/personal-kinetigraph-pkg-system-gyd",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "device": {
    "name": "Personal Kinetigraph (Pkg) System",
    "registry_name": "PERSONAL KINETIGRAPH (PKG) SYSTEM",
    "url": "https://devicerts.com/devices/personal-kinetigraph-pkg-system-gyd",
    "manufacturer": {
      "name": "Gkc Manufacturing Pty Ltd",
      "url": "https://devicerts.com/manufacturers/gkc-manufacturing-pty-ltd",
      "country": "Australia",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K140086",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "GYD"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The Personal Kinetigraph (PKG) System GKC-2000 is a Class II medical device classified as a Transducer, Tremor (product code GYD). It is designed to measure and quantify kinematic data related to movement disorders, including tremor, bradykinesia, and dyskinesia, aiding in the assessment of neurological conditions such as Parkinson’s disease. The system captures real-time motion data to evaluate symptom severity and treatment response. Its regulatory classification under 882.1950 reflects its role in diagnostic monitoring of tremor-related pathologies.\n\nThe PKG System GKC-2000 is supplied as a portable, wearable device paired with a PKG Smart Charger for battery management. It operates in non-sterile environments and is intended for single-use or reusable applications, depending on clinical protocols. The device is MRI-unsafe and must be removed prior to MRI procedures. Storage requires protection from extreme temperatures and physical damage. Authorized under FDA 510(k) clearance (K140086), it adheres to special controls for Class II devices, ensuring compliance with regulatory standards for tremor assessment technologies.",
      "ai_generated": true,
      "generated_on": "2026-10-01",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K140086",
      "number_label": null,
      "device_udi_di": null,
      "date": "2014-08-22",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K140086",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "GYD",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class II",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 882.1950",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Neurology",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA decision",
          "values": [
            {
              "value": "SESE",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    }
  ]
}