Personal Kinetigraph (PKG)

Primary DI
09359011000303
Brand
Personal Kinetigraph (PKG)
Company
GKC MANUFACTURING PTY LTD
Model
2000-LOG-004
Device description
The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms in conditions such asParkinson's disease, including tremor, bradykinesia and dyskinesia.
Published
2023-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09359011000303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09359011000303093590110003039359011000303

GMDN Terms#

Term, Definition table
TermDefinition
Neuromuscular motion disorder ambulatory recorder/analyserAn 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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
742903370
Device count
1
DM exempt
true
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09369998308569Personal Kinetigraph (PKG)2001-CHG-DOC-US2019-04-25
09359011000297Personal KinetiGraph (PKG)2022-CHG-DOC-V1.22023-10-20
09359011000327Personal KinetiGraph (PKG)2022-CHG-DOC-UNI2024-02-16
09359011000280Personal KinetiGraph (PKG)2023-LOG-G32023-10-23
09359011000310Personal KinetiGraph (PKG)2022-CHG-DOC-0042023-10-20
09369998107773Personal Kinetigraph (PKG) GKC-20002017-11-08
09369998208654Personal Kinetigraph (PKG) GKC-20002017-11-08
09369998040162Personal Kinetigraph (PKG)GKC-20092019-04-26
09369998000562Personal Kinetigraph (PKG)2001-CHG-DOC-US2019-04-25