GYD
- Product code
- GYD
- Device name
- Transducer, Tremor
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.1950
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 15
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name |
|---|---|---|---|
| K262515 | 2026-08-20 | Kneu Health Digital , Ltd. | Kneu Platform (V2) summary |
| K260374 | 2026-08-14 | Empatica S.r.l. | Empatica Health Monitoring Platform for Parkinson's summary |
| K253055 | 2026-06-17 | Nordic Kinetics AB | Sine Monitoring Parkinsons Disease Tremor Dyskinesi summary |
| K250153 | 2025-04-25 | Neuhealth Digital , Ltd. | Neu Platform summary |
Official FDA classification page: GYD
Classification and pathway per current FDA publications. Data from openFDA (CC0).