Personal Kinetigraph (PKG) System Gen 2 Plus
GKC Manufacturing Pty Ltd
GKC MANUFACTURING PTY LTD
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3011196543 | 3011196543 | GKC MANUFACTURING PTY LTD | 1 | N | 2026-01-01 | Level 9, 31 Queen Street Melbourne Victoria AU 3000 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 174608 | 1216259846 | K211887 | Personal Kinetigraph (PKG) System Gen 2 Plus | GYD | 2022-03-11 |
| 174608 | 1591079418 | K161717 | Personal Kinetigraph (PKG) System | GYD | 2016-09-20 |
| 174608 | 1338712570 | K140086 | PERSONAL KINETIGRAPH (PKG) SYSTEM | GYD | 2014-08-22 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GYD | 3 | 2022-03-11 |
PMN#
Personal Kinetigraph (PKG) System
GKC MANUFACTURING PTY LTD.
PERSONAL KINETIGRAPH (PKG) SYSTEM
GKC MANUFACTURING PTY LTD.
GUDID#
Personal Kinetigraph (PKG) - The PKG Smart Charger is a portable charging station to be used in conjunction with GKC-2000 deviceThe Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia and dyskinesia.
2019-04-25
Personal KinetiGraph (PKG) - 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.
2023-10-20
Personal KinetiGraph (PKG) - 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.
2024-02-16
Personal KinetiGraph (PKG) - 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.
2023-10-23
Personal Kinetigraph (PKG) - The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms in conditions such asParkinson's disease, including tremor, bradykinesia and dyskinesia.
2023-10-20
Personal KinetiGraph (PKG) - The PKG Smart Charger is a portable charging station to be used in conjunction with 2000-LOG-004 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.
2023-10-20
Personal Kinetigraph (PKG) - The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms in conditions such asParkinson's disease, including tremor, bradykinesia and dyskinesia.
2017-11-08
Personal Kinetigraph (PKG) - 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.
2017-11-08
Personal Kinetigraph (PKG) - The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms such as Parkinson's disease, including tremor, bradykinesia and dyskinesia
2019-04-26
Personal Kinetigraph (PKG) - 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.
2019-04-25