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Personal Kinetigraph (PKG)

FDA UDI

by Gkc Manufacturing Pty Ltd

Identity

Trade Name
Personal Kinetigraph (PKG) FDA UDI
Generic Name
Neuromuscular motion disorder ambulatory recorder/analyser FDA UDI
Device Name
The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms such as Parkinson's disease, including tremor, bradykinesia and dyskinesia FDA UDI
Model / Reference
GKC-2009 FDA UDI
Description
The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms such as Parkinson's disease, including tremor, bradykinesia and dyskinesia FDA UDI

Identifiers

Primary DI / UDI-DI
09369998040162 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

Yes

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gkc Manufacturing Pty Ltd

Sources (1)

  • FDA UDI 64b71fad-defc-4f89-aa78-31032d1c82cd 33 fields · synced May 30, 2026