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510(k) K220820

Parky App by H2o Bilisim Yazilim — Product Code GYD

K220820 is an FDA 510(k) premarket notification submitted by H2o Bilisim Yazilim for the device "Parky App". The FDA issued a decision of Substantially Equivalent on November 17, 2022. The device falls under product code GYD (Transducer, Tremor), a Class II device regulated under 21 CFR 882.1950.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2022
Date Received
March 21, 2022
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 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)
  • K213519 — Rune Labs Tremor Transducer System (June 10, 2022)
  • K211887 — Personal Kinetigraph (PKG) System Gen 2 Plus (March 11, 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