Kinesia
FDA 510(k) K063872 · Cleveland Medical Devices, Inc.
510(k) numberK063872
Submission
- Device name
- Kinesia
- Applicant
- Cleveland Medical Devices, Inc.
Cleveland, OH, US - Received
- December 29, 2006
- Decision date
- April 6, 2007
- 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 |
| K211887 | Personal Kinetigraph (PKG) System Gen 2 PlusGYD · Traditional | Gkc Manufacturing Pty, Ltd. | 03/11/2022SE |
| 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 |
More from Gkc Manufacturing Pty, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K042039 | Family of Crystal 20 Monitors Model #CS20-600,900,1300,1400,2400 & 120OLV · Traditional | 11/17/2004SE |
| K013863 | Crystal Monitor Model 16OMC · Traditional | 02/19/2002SE |
| K001110 | Crystal-Eeg Model 15OMC · Traditional | 07/05/2000SE |
| K970672 | Crystal-Eeg Model 10 (Model 10)OMC · Traditional | 05/22/1997SE |
| K964690 | Liberty ValveKNX · Traditional | 03/21/1997SE |
| K962591 | Foot Weight AlarmIRN · Traditional | 12/04/1996SE |
| K954670 | Pressore MonitorIKE · Traditional | 10/30/1995SE |
Questions and answers
When was Kinesia cleared by the FDA?
Kinesia (K063872) received a 510(k) decision of Substantially Equivalent on April 6, 2007, 98 days after the submission was received.
What is the product code of K063872?
The FDA product code is GYD – Transducer, Tremor, a Class II (moderate risk) device regulated under 21 CFR 882.1950.