Home / 510(k) Clearances / K211887

510(k) K211887

Personal Kinetigraph (PKG) System Gen 2 Plus by Gkc Manufacturing Pty, Ltd. — Product Code GYD

K211887 is an FDA 510(k) premarket notification submitted by Gkc Manufacturing Pty, Ltd. for the device "Personal Kinetigraph (PKG) System Gen 2 Plus". The FDA issued a decision of Substantially Equivalent on March 11, 2022. 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
March 11, 2022
Date Received
June 21, 2021
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.

  • K161717 — Personal Kinetigraph (PKG) System (September 20, 2016)
  • 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)
  • K161717 — Personal Kinetigraph (PKG) System (September 20, 2016)
  • 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