Personal KinetiGraph (PKG)

GUDID 09359011000297

The PKG Smart Charger is a portable charging station to be used in conjunction with GKC-2000 device 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.

GKC MANUFACTURING PTY LTD

Neuromuscular motion disorder ambulatory recorder/analyser Neuromuscular motion disorder ambulatory recorder/analyser Neuromuscular motion disorder ambulatory recorder/analyser Neuromuscular motion disorder ambulatory recorder/analyser Neuromuscular motion disorder ambulatory recorder/analyser Neuromuscular motion disorder ambulatory recorder/analyser Neuromuscular motion disorder ambulatory recorder/analyser Neuromuscular motion disorder ambulatory recorder/analyser Neuromuscular motion disorder ambulatory recorder/analyser Neuromuscular motion disorder ambulatory recorder/analyser Neuromuscular motion disorder ambulatory recorder/analyser Neuromuscular motion disorder ambulatory recorder/analyser Neuromuscular motion disorder ambulatory recorder/analyser Neuromuscular motion disorder ambulatory recorder/analyser Neuromuscular motion disorder ambulatory recorder/analyser Neuromuscular motion disorder ambulatory recorder/analyser Neuromuscular motion disorder ambulatory recorder/analyser
Primary Device ID09359011000297
NIH Device Record Key9f0c4e46-5945-4e8e-abb3-a956156b6aed
Commercial Distribution StatusIn Commercial Distribution
Brand NamePersonal KinetiGraph (PKG)
Version Model Number2022-CHG-DOC-V1.2
Company DUNS742903370
Company NameGKC MANUFACTURING PTY LTD
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109359011000297 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-30
Device Publish Date2023-10-20

On-Brand Devices [Personal KinetiGraph (PKG)]

09369998000562The PKG Smart Charger is a portable charging station to be used in conjunction with GKC-2000 dev
09369998040162The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms
09369998208654The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms
09359011000310The PKG Smart Charger is a portable charging station to be used in conjunction with 2000-LOG-004
09359011000303The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms
09359011000297The PKG Smart Charger is a portable charging station to be used in conjunction with GKC-2000 dev
09359011000280The Personal KinetiGraph (PKG) is intended to quantify kinematics of movement disorder symptoms
09359011000327The PKG Smart Charger is a portable charging station to be used in conjunction with GKC-2000 dev

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