GYD — Transducer, Tremor Class II
FDA Device Classification
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 |
| 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 |