PERSONAL KINETIGRAPH (PKG) SYSTEM— 510(k) K140086

Name: FDA 510(k) clearance K140086
Creator: U.S. Food and Drug Administration
Published: 2014-08-22

Substantially Equivalent

Gkc Manufacturing Pty, Ltd.

FDA 510(k) clearance K140086 for PERSONAL KINETIGRAPH (PKG) SYSTEM, Substantially Equivalent on 2014-08-22. Applicant: Gkc Manufacturing Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Gkc Manufacturing Pty, Ltd.
Product code: Code GYD
Device class: Class 2
Regulation: 21 CFR 882.1950
Advisory panel: Neurology
Date received: 2014-01-14
Decision date: 2014-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GYD

view all

K262515 — Kneu Platform (V2)2026-08-20
K260374 — Empatica Health Monitoring Platform for Parkinson's Disease Monitoring +5 more2026-08-14
K253055 — Sine Monitoring Parkinsons Disease Tremor Dyskinesia Apple Watch (SMPDTDAW)2026-06-17
K250153 — Neu Platform2025-04-25
K221772 — NeuroRPM2023-03-17

More clearances from Gkc Manufacturing Pty, Ltd.

view all

K211887 — Personal Kinetigraph (PKG) System Gen 2 Plus2022-03-11
K161717 — Personal Kinetigraph (PKG) System2016-09-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.