Personal Kinetigraph (PKG) System Gen 2 Plus
FDA 510(k) K211887 · Gkc Manufacturing Pty, Ltd.
510(k) numberK211887
Submission
- Device name
- Personal Kinetigraph (PKG) System Gen 2 Plus
- Applicant
- Gkc Manufacturing Pty, Ltd.
Melbourne, AU - Received
- June 21, 2021
- Decision date
- March 11, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GYD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262515 | Kneu Platform (V2)GYD · Traditional | Kneu Health Digital , Ltd. | 08/20/2026SE |
| K260374 | Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…GYD · Traditional | Empatica S.r.l. | 08/14/2026SE |
| K253055 | Sine Monitoring Parkinsons Disease Tremor Dyskinesia Apple Watch (SMPDTDAW)GYD · Traditional | Nordic Kinetics AB | 06/17/2026SE |
| K250153 | Neu PlatformGYD · Traditional | Neuhealth Digital , Ltd. | 04/25/2025SE |
| K221772 | NeuroRPMGYD · Traditional | New Touch Digital, Inc. | 03/17/2023SE |
| K220820 | Parky AppGYD · Traditional | H2o Bilisim Yazilim | 11/17/2022SE |
| K213519 | Rune Labs Tremor Transducer SystemGYD · Traditional | Rune Labs, Inc. | 06/10/2022SE |
| K161717 | Personal Kinetigraph (PKG) SystemGYD · Traditional | Gkc Manufacturing Pty, Ltd. | 09/20/2016SE |
| K140086 | Personal Kinetigraph (PKG) SystemGYD · Traditional | Gkc Manufacturing Pty, Ltd. | 08/22/2014SE |
| K063872 | KinesiaGYD · Traditional | Cleveland Medical Devices, Inc. | 04/06/2007SE |
More from Cleveland Medical Devices, Inc.
Questions and answers
When was Personal Kinetigraph (PKG) System Gen 2 Plus cleared by the FDA?
Personal Kinetigraph (PKG) System Gen 2 Plus (K211887) received a 510(k) decision of Substantially Equivalent on March 11, 2022, 263 days after the submission was received.
What is the product code of K211887?
The FDA product code is GYD – Transducer, Tremor, a Class II (moderate risk) device regulated under 21 CFR 882.1950.