Identity
- Trade Name
- Personal KinetiGraph (PKG) FDA UDI
- Generic Name
- Neuromuscular motion disorder ambulatory recorder/analyser FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 2022-CHG-DOC-V1.2 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09359011000297 FDA UDI
- GMDN Term
- Neuromuscular motion disorder ambulatory recorder/analyser FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Neuromuscular motion disorder ambulatory recorder/analyser
Personal KinetiGraph (PKG) by Gkc Manufacturing Pty Ltd — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Neuromuscular motion disorder ambulatory recorder/analyser.
- Personal KinetiGraph (PKG) — GKC MANUFACTURING PTY LTD
- Personal KinetiGraph (PKG) — GKC MANUFACTURING PTY LTD
- Personal Kinetigraph (PKG) — GKC MANUFACTURING PTY LTD
- Personal Kinetigraph (PKG) — GKC MANUFACTURING PTY LTD
- Personal Kinetigraph (PKG) — GKC MANUFACTURING PTY LTD
- Personal KinetiGraph (PKG) — GKC MANUFACTURING PTY LTD
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Gkc Manufacturing Pty Ltd
Sources (1)
- FDA UDI 9f0c4e46-5945-4e8e-abb3-a956156b6aed 33 fields · synced Jun 1, 2026