Product code GYD
- Device name
- Transducer, Tremor
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.1950
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250153 | Neu Platform | Neuhealth Digital , Ltd. | 2025-04-25 |
| K221772 | NeuroRPM | New Touch Digital, Inc. | 2023-03-17 |
| K220820 | Parky App | H2o Bilisim Yazilim | 2022-11-17 |
| K213519 | Rune Labs Tremor Transducer System | Rune Labs, Inc. | 2022-06-10 |
| K211887 | Personal Kinetigraph (PKG) System Gen 2 Plus | Gkc Manufacturing Pty, Ltd. | 2022-03-11 |
| K161717 | Personal Kinetigraph (PKG) System | Gkc Manufacturing Pty, Ltd. | 2016-09-20 |
| K140086 | PERSONAL KINETIGRAPH (PKG) SYSTEM | Gkc Manufacturing Pty, Ltd. | 2014-08-22 |
| K063872 | KINESIA | Cleveland Medical Devices, Inc. | 2007-04-06 |
| K010270 | TREMOROMETER | Flexable Systems, Inc. | 2001-07-25 |
| K011429 | MODEL 100 ACTIVITY MONITOR | Telecom Medical, Inc. | 2001-07-13 |
| K971318 | MM-1 MOVEMENT MONITOR | Axon Instruments, Inc. | 1997-07-28 |
| K782036 | TREMOR MONITOR | Columbus Instruments Intl. Corp. | 1979-01-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00859584006157 | KinesiaU | Great Lakes Neurotechnologies Inc. | 2024-01-03 |
| 00860009869707 | Parky | H2O BILISIM YAZILIM ELEKTRONIK SAGLIK HIZMETLERI SANAYI VE TICARET LIMITED SIRKETI | 2023-03-27 |
| 00859584006140 | Kinesia One-C | Great Lakes Neurotechnologies Inc. | 2022-08-24 |
| 00859584006102 | KinesiaU (iOS) | Great Lakes Neurotechnologies Inc. | 2021-02-17 |
| 00859584006096 | KinesiaU | Great Lakes Neurotechnologies Inc. | 2019-10-21 |
| 00859584006270 | Kinesia 360 | Great Lakes Neurotechnologies Inc. | 2019-01-28 |
| 00859584006263 | Kinesia 360 | Great Lakes Neurotechnologies Inc. | 2018-06-27 |
| 00859584006256 | Kinesia 360 | Great Lakes Neurotechnologies Inc. | 2018-06-27 |
| 00859584006249 | Kinesia | Great Lakes Neurotechnologies Inc. | 2018-06-27 |
| 00859584006232 | Kinesia | Great Lakes Neurotechnologies Inc. | 2018-06-27 |
| 00859584006225 | Kinesia StimPoint | Great Lakes Neurotechnologies Inc. | 2018-06-27 |
| 00859584006218 | Kinesia StimPoint | Great Lakes Neurotechnologies Inc. | 2018-06-27 |
| 00859584006201 | Kinesia StimPoint | Great Lakes Neurotechnologies Inc. | 2018-06-27 |
| 00859584006195 | Kinesia StimPoint | Great Lakes Neurotechnologies Inc. | 2018-06-27 |
| 00859584006188 | Kinesia StimPoint | Great Lakes Neurotechnologies Inc. | 2018-06-27 |
| 00859584006171 | Kinesia 360 | Great Lakes Neurotechnologies Inc. | 2017-02-23 |
| 00859584006164 | Kinesia | Great Lakes Neurotechnologies Inc. | 2016-11-10 |
| 00859584006027 | Kinesia One | Great Lakes Neurotechnologies Inc. | 2016-09-13 |
| 00859584006133 | Kinesia | Great Lakes Neurotechnologies Inc. | 2016-09-13 |
| 00859584006126 | Kinesia 360 | Great Lakes Neurotechnologies Inc. | 2016-09-13 |
| 00859584006119 | Kinesia One | Great Lakes Neurotechnologies Inc. | 2016-09-13 |
| 00859584006089 | Kinesia 360 | Great Lakes Neurotechnologies Inc. | 2016-09-13 |
| 00859584006072 | Kinesia 360 | Great Lakes Neurotechnologies Inc. | 2016-09-13 |
| 00859584006065 | Kinesia 360 | Great Lakes Neurotechnologies Inc. | 2016-09-13 |
| 00859584006058 | Kinesia 360 | Great Lakes Neurotechnologies Inc. | 2016-09-13 |
| 00859584006041 | Kinesia One | Great Lakes Neurotechnologies Inc. | 2016-09-13 |
| 00859584006034 | Kinesia One | Great Lakes Neurotechnologies Inc. | 2016-09-13 |
| 00859584006010 | Kinesia One | Great Lakes Neurotechnologies Inc. | 2016-09-13 |
| 00859584006003 | Kinesia One | Great Lakes Neurotechnologies Inc. | 2016-09-12 |