Personal Kinetigraph System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K161717 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 System is a Class II medical device classified as a transducer for tremor assessment, designed to objectively measure and record involuntary movements. It provides continuous, non-invasive monitoring of tremor activity, enabling clinicians to evaluate neurological conditions such as Parkinson’s disease or essential tremor with quantitative data.
The system is supplied as a reusable device with disposable sensor attachments, intended for use in clinical or research settings. It operates in environments compatible with MRI safety standards and is regulated under FDA 510(k) clearance and EU MDR compliance. Storage requires adherence to manufacturer guidelines for sensor hygiene and device calibration, ensuring accurate and reliable performance for diagnostic purposes.
Frequently asked questions
What types of neurological conditions can the Personal Kinetigraph System help assess with its tremor measurement technology?
The Personal Kinetigraph System is designed to objectively measure involuntary movements, particularly tremors, which are commonly associated with neurological conditions like Parkinson’s disease and essential tremor. By providing continuous, non-invasive monitoring, it helps clinicians evaluate tremor activity with quantitative data to aid in diagnosis or treatment planning.
Is the Personal Kinetigraph System safe to use in MRI-compatible environments, and how does this benefit clinical workflows?
Yes, the Personal Kinetigraph System is designed to operate in environments compatible with MRI safety standards. This allows clinicians to use the device alongside MRI scans without interference, streamlining diagnostic workflows for patients with neurological conditions like tremor disorders.
How is the Personal Kinetigraph System supplied, and what does this mean for cost and maintenance in a clinical setting?
The system is supplied as a reusable device with disposable sensor attachments. This means the core unit can be used repeatedly, reducing long-term costs, while the single-use sensors ensure hygiene and prevent cross-contamination between patients. Clinics will need to follow manufacturer guidelines for sensor disposal and device calibration to maintain accuracy.
What regulatory pathways does the Personal Kinetigraph System follow, and how does this affect its availability in different markets?
The Personal Kinetigraph System has obtained FDA 510(k) clearance and complies with EU MDR (Medical Device Regulation). This dual regulatory approval allows the device to be legally marketed in the U.S. and European Economic Area, ensuring broader accessibility for clinicians assessing tremor-related neurological conditions in those regions.
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.
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 | K161717 | Class II | Active |
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Manufacturer
- Manufacturer
- Gkc Manufacturing Pty Ltd
- FDA Applicant
- Gkc Manufacturing Pty, Ltd.
Sources (2)
- FDA 510(k) K161717 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 29, 2026