GYD — Transducer, Tremor Class II
FDA product code GYD covers "Transducer, Tremor", a Class II medical device regulated under 21 CFR 882.1950. Submissions are reviewed by the Neurology panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GYD
- Device Class
- Class II
- Regulation Number
- 882.1950
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253055 | nordic kinetics | Sine Monitoring Parkinsons Disease Tremor Dyskinesia Apple Watch (SMPDTDAW) | June 17, 2026 |
| K250153 | neuhealth digital | Neu Platform | April 25, 2025 |
| K221772 | new touch digital | NeuroRPM | March 17, 2023 |
| K220820 | h2o bilisim yazilim | Parky App | November 17, 2022 |
| K213519 | rune labs | Rune Labs Tremor Transducer System | June 10, 2022 |
| K211887 | gkc manufacturing pty | Personal Kinetigraph (PKG) System Gen 2 Plus | March 11, 2022 |
| K161717 | gkc manufacturing pty | Personal Kinetigraph (PKG) System | September 20, 2016 |
| K140086 | gkc manufacturing pty | PERSONAL KINETIGRAPH (PKG) SYSTEM | August 22, 2014 |
| K063872 | cleveland medical devices | KINESIA | April 6, 2007 |
| K010270 | flexable systems | TREMOROMETER | July 25, 2001 |
| K011429 | telecom medical | MODEL 100 ACTIVITY MONITOR | July 13, 2001 |
| K971318 | axon instruments | MM-1 MOVEMENT MONITOR | July 28, 1997 |
| K782036 | columbus instruments intl | TREMOR MONITOR | January 23, 1979 |