FDA Product Code
FDA Product Code GYD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1950
510(k) Clearances — 15 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262515 | Kneu Platform (V2) | Kneu Health Digital , Ltd. | 2026-08-20 | Traditional | PDF ↗ |
| K260374 | Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal | Empatica S.r.l. | 2026-08-14 | Traditional | PDF ↗ |
| K253055 | Sine Monitoring Parkinsons Disease Tremor Dyskinesia Apple Watch (SMPDTDAW) | Nordic Kinetics AB | 2026-06-17 | Traditional | PDF ↗ |
| K250153 | Neu Platform | Neuhealth Digital , Ltd. | 2025-04-25 | Traditional | PDF ↗ |
| K221772 | NeuroRPM | New Touch Digital, Inc. | 2023-03-17 | Traditional | PDF ↗ |
| K220820 | Parky App | H2o Bilisim Yazilim | 2022-11-17 | Traditional | PDF ↗ |
| K213519 | Rune Labs Tremor Transducer System | Rune Labs, Inc. | 2022-06-10 | Traditional | PDF ↗ |
| K211887 | Personal Kinetigraph (PKG) System Gen 2 Plus | Gkc Manufacturing Pty, Ltd. | 2022-03-11 | Traditional | PDF ↗ |
| K161717 | Personal Kinetigraph (PKG) System | Gkc Manufacturing Pty, Ltd. | 2016-09-20 | Traditional | PDF ↗ |
| K140086 | PERSONAL KINETIGRAPH (PKG) SYSTEM | Gkc Manufacturing Pty, Ltd. | 2014-08-22 | Traditional | PDF ↗ |
| K063872 | KINESIA | Cleveland Medical Devices, Inc. | 2007-04-06 | Traditional | PDF ↗ |
| K010270 | TREMOROMETER | Flexable Systems, Inc. | 2001-07-25 | Traditional | PDF ↗ |
| K011429 | MODEL 100 ACTIVITY MONITOR | Telecom Medical, Inc. | 2001-07-13 | Traditional | PDF ↗ |
| K971318 | MM-1 MOVEMENT MONITOR | Axon Instruments, Inc. | 1997-07-28 | Traditional | PDF ↗ |
| K782036 | TREMOR MONITOR | Columbus Instruments Intl. Corp. | 1979-01-23 | Traditional | PDF ↗ |
Product code GYD · Class II · Neurology. Data: openFDA.