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)
- 4
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 15 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K262515 | 2026-08-20 | Kneu Health Digital , Ltd. | Kneu Platform (V2) | FDA |
| K260374 | 2026-08-14 | Empatica S.r.l. | Empatica Health Monitoring Platform for Parkinson's … | |
| K253055 | 2026-06-17 | Nordic Kinetics AB | Sine Monitoring Parkinsons Disease Tremor Dyskinesi… | |
| K250153 | 2025-04-25 | Neuhealth Digital , Ltd. | Neu Platform |
Official FDA classification page: GYD
Classification and pathway per current FDA publications. Data from openFDA (CC0).