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510(k) K161717

Personal Kinetigraph (PKG) System by Gkc Manufacturing Pty, Ltd. — Product Code GYD

K161717 is an FDA 510(k) premarket notification submitted by Gkc Manufacturing Pty, Ltd. for the device "Personal Kinetigraph (PKG) System". The FDA issued a decision of Substantially Equivalent on September 20, 2016. The device falls under product code GYD (Transducer, Tremor), a Class II device regulated under 21 CFR 882.1950. Gkc Manufacturing Pty, Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2016
Date Received
June 22, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Tremor
Device Class
Class II
Regulation Number
882.1950
Review Panel
NE
Submission Type

Other clearances by Gkc Manufacturing Pty, Ltd.

  • K211887 — Personal Kinetigraph (PKG) System Gen 2 Plus (March 11, 2022)
  • K140086 — PERSONAL KINETIGRAPH (PKG) SYSTEM (August 22, 2014)

Other clearances for product code GYD

  • K253055 — Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”) (June 17, 2026)
  • K250153 — Neu Platform (April 25, 2025)
  • K221772 — NeuroRPM (March 17, 2023)
  • K220820 — Parky App (November 17, 2022)
  • K213519 — Rune Labs Tremor Transducer System (June 10, 2022)
  • K211887 — Personal Kinetigraph (PKG) System Gen 2 Plus (March 11, 2022)
  • K140086 — PERSONAL KINETIGRAPH (PKG) SYSTEM (August 22, 2014)
  • K063872 — KINESIA (April 6, 2007)
  • K010270 — TREMOROMETER (July 25, 2001)
  • K011429 — MODEL 100 ACTIVITY MONITOR (July 13, 2001)

FDA data resources