GYD
13 FDA 510(k) clearances · Product code
177 daysmedian time to decision
268 days90th percentile
13clearances measured
FDA profile
- Official device name
- Transducer, Tremor
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1950
- Medical specialty
- Neurology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”) (K253055) | Nordic Kinetics AB | 2026-06-17 |
| Neu Platform (K250153) | Neuhealth Digital , Ltd. | 2025-04-25 |
| NeuroRPM (K221772) | New Touch Digital, Inc. | 2023-03-17 |
| Parky App (K220820) | H2o Bilisim Yazilim | 2022-11-17 |
| Rune Labs Tremor Transducer System (K213519) | Rune Labs, Inc. | 2022-06-10 |
| Personal Kinetigraph (PKG) System Gen 2 Plus (K211887) | Gkc Manufacturing Pty, Ltd. | 2022-03-11 |
| Personal Kinetigraph (PKG) System (K161717) | Gkc Manufacturing Pty, Ltd. | 2016-09-20 |
| PERSONAL KINETIGRAPH (PKG) SYSTEM (K140086) | Gkc Manufacturing Pty, Ltd. | 2014-08-22 |
| KINESIA (K063872) | Cleveland Medical Devices, Inc. | 2007-04-06 |
| TREMOROMETER (K010270) | Flexable Systems, Inc. | 2001-07-25 |
| MODEL 100 ACTIVITY MONITOR (K011429) | Telecom Medical, Inc. | 2001-07-13 |
| MM-1 MOVEMENT MONITOR (K971318) | Axon Instruments, Inc. | 1997-07-28 |
| TREMOR MONITOR (K782036) | Columbus Instruments Intl. Corp. | 1979-01-23 |
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Every clearance here is in the API, with alerts when new ones post.