Product code GYD— Neurology
Empatica Health Monitoring Platform for Parkinson's Disease Monitoring +5 more
- Classification name
- Transducer, Tremor
- Device class
- Class 2
- Regulation
- 21 CFR 882.1950
- Advisory panel
- Neurology
- Total cleared
- 15
- First cleared
- Most recent
Market context for product code GYD
FDA has cleared devices under product code GYD between 1979 and 2026, filed by 13 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2026
- 2025
- 2023
- 2022
- 2016
- 2014
- 2007
- 2001
- 1997
- 1979
Top applicants under product code GYD
Recent clearances under product code GYD
- K262515 — Kneu Platform (V2)
- K260374 — Empatica Health Monitoring Platform for Parkinson's Disease Monitoring +5 more
- K253055 — Sine Monitoring Parkinsons Disease Tremor Dyskinesia Apple Watch (SMPDTDAW)
- K250153 — Neu Platform
- K221772 — NeuroRPM
- K220820 — Parky App
- K213519 — Rune Labs Tremor Transducer System
- K211887 — Personal Kinetigraph (PKG) System Gen 2 Plus
- K161717 — Personal Kinetigraph (PKG) System
- K140086 — PERSONAL KINETIGRAPH (PKG) SYSTEM
- K063872 — KINESIA
- K010270 — TREMOROMETER
- K011429 — MODEL 100 ACTIVITY MONITOR
- K971318 — MM-1 MOVEMENT MONITOR
- K782036 — TREMOR MONITOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.