Parky App

FDA 510(k) K220820 · H2o Bilisim Yazilim

Substantially Equivalent

510(k) numberK220820

Submission

Device name
Parky App
Applicant
H2o Bilisim Yazilim
Cankaya, TR
Received
March 21, 2022
Decision date
November 17, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GYD – Transducer, Tremor
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1950
Specialty
Neurology

Other 510(k)s with product code GYD

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K253055Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”)GYD · Traditional Nordic Kinetics AB06/17/2026SE
K250153Neu PlatformGYD · Traditional Neuhealth Digital , Ltd.04/25/2025SE
K221772NeuroRPMGYD · Traditional New Touch Digital, Inc.03/17/2023SE
K213519Rune Labs Tremor Transducer SystemGYD · Traditional Rune Labs, Inc.06/10/2022SE
K211887Personal Kinetigraph (PKG) System Gen 2 PlusGYD · Traditional Gkc Manufacturing Pty, Ltd.03/11/2022SE
K161717Personal Kinetigraph (PKG) SystemGYD · Traditional Gkc Manufacturing Pty, Ltd.09/20/2016SE
K140086Personal Kinetigraph (PKG) SystemGYD · Traditional Gkc Manufacturing Pty, Ltd.08/22/2014SE
K063872KinesiaGYD · Traditional Cleveland Medical Devices, Inc.04/06/2007SE

Questions and answers

When was Parky App cleared by the FDA?

Parky App (K220820) received a 510(k) decision of Substantially Equivalent on November 17, 2022, 241 days after the submission was received.

What is the product code of K220820?

The FDA product code is GYD – Transducer, Tremor, a Class II (moderate risk) device regulated under 21 CFR 882.1950.