Personal Kinetigraph (PKG) System Gen 2 Plus
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K211887 FDA 510(k)
- FDA Product Code
- GYD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1950 FDA 510(k)
- Regulation Number
- 882.1950 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Personal Kinetigraph (PKG) System Gen 2 Plus is a Transducer, Tremor (product code GYD), classified under Class II with Special Controls. It is designed to measure and record tremors, providing objective data for neurological assessment, particularly in the evaluation of movement disorders such as Parkinson’s disease or essential tremor. The system captures continuous kinematic data to aid in clinical diagnosis and treatment planning.
This device is supplied as a reusable system with multiple transducer attachments (FEI numbers: 3011196543, 3032027298, 3012933969, 3009134706) for placement on different body parts. It operates in clinical and research settings, with regulatory authorisations including FDA 510K clearance and MDR compliance. No specific MRI safety classification is stated, and storage requirements are not detailed in the available data.
Frequently asked questions
What types of tremors can the Personal Kinetograph (PKG) System Gen 2 Plus measure, and how does it help in clinical assessment?
The Personal Kinetograph (PKG) System Gen 2 Plus is specifically designed to measure and record tremors, providing objective kinematic data for neurological assessment. It is particularly useful in evaluating movement disorders such as Parkinson’s disease or essential tremor. By capturing continuous motion data, it aids clinicians in diagnosing these conditions and supports treatment planning by offering detailed insights into tremor characteristics.
Is the Personal Kinetograph (PKG) System Gen 2 Plus intended for single-use or reusable applications?
The PKG System Gen 2 Plus is supplied as a reusable system. This means it is designed for repeated use in clinical and research settings, allowing for long-term monitoring and data collection across multiple patients or assessments. The reusable nature also supports cost efficiency and sustainability in healthcare environments.
What body parts can the Personal Kinetograph (PKG) System Gen 2 Plus be attached to, and how does this flexibility benefit users?
The system includes multiple transducer attachments (FEI numbers: 3011196543, 3032027298, 3012933969, 3009134706) that can be placed on different body parts. This flexibility allows clinicians to assess tremors in various locations, such as hands, arms, or other affected areas, providing a comprehensive evaluation of movement disorders. The adaptability ensures accurate data collection tailored to the patient’s specific symptoms.
What regulatory pathways has the Personal Kinetograph (PKG) System Gen 2 Plus undergone, and how does this impact its use?
The PKG System Gen 2 Plus has undergone regulatory review through the FDA’s 510(k) clearance process and complies with the EU’s Medical Device Regulation (MDR). These authorizations confirm that the device meets established safety and performance standards for Class II devices under the product code GYD (Transducer, Tremor). Clinicians and researchers can rely on its compliance for clinical and research use in neurology, ensuring trust in its diagnostic accuracy and reliability.
How does the PKG System Gen 2 Plus differ from other tremor assessment tools in terms of its approach to data collection?
Unlike some tremor assessment tools that rely on subjective patient reports or limited sampling, the PKG System Gen 2 Plus captures continuous kinematic data, providing real-time, objective measurements of tremor characteristics. This approach enhances diagnostic precision by offering detailed insights into tremor frequency, amplitude, and patterns, which are critical for accurate assessment and personalized treatment planning in movement disorders like Parkinson’s disease or essential tremor.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Personal Kinetigraph (PKG) System Gen 2 Plus (K211887 ... - fda ..., K211887 - Personal Kinetigraph (PKG) System Gen 2..., PDF K211887 - Personal Kinetigraph (PKG) System Gen 2 Plus, PDF Kathy Herzog Regulatory Consultant Suite 1820, Medical Arts Building ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K211887 | Class II | Active |
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Manufacturer
- Manufacturer
- Gkc Manufacturing Pty Ltd
- FDA Applicant
- Gkc Manufacturing Pty, Ltd.
Sources (2)
- FDA 510(k) K211887 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026