Personal Kinetigraph (PKG)

Basic Information

• Brand Name: Personal Kinetigraph (PKG)
• Primary DI: 09359011000303
• Version / Model: 2000-LOG-004
• Company Name: GKC MANUFACTURING PTY LTD
• Labeler DUNS: 742903370
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-20
• Public Version: 1
• Public Version Date: 2023-10-30
• Public Version Status: New
• Public Device Record Key: f3dc0201-9a32-405c-829c-40998f32577f

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
61125	Neuromuscular motion disorder ambulatory recorder/analyser	An assembly of devices intended for 24-hour recording of body movements of a patient affected by a neuromuscular kinetic disorder (e.g., Parkinson’s disease) for analysis. It consists of battery-powered, home-use, externally-worn (e.g., wrist, leg, head) patient motion sensors worn during activities of daily living, a computing device/software for data analysis, and the appropriate connection cables. Stored data is retrieved from the patient recorder and analysed to provide a report (e.g., bradykinesia and dyskinesia severity score).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09359011000303	GS1