GYD · Transducer, Tremor
Neurology · 21 CFR 882.1950 · Class 2
Overview
| Product Code | GYD |
|---|---|
| Device Name | Transducer, Tremor |
| Regulation | 21 CFR 882.1950 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
A tremor transducer is a device used to measure the degree of tremor caused by certain diseases.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250153 | Neu Platform | Neuhealth Digital , Ltd. | Apr 25, 2025 | SESE |
| K221772 | NeuroRPM | New Touch Digital, Inc. | Mar 17, 2023 | SESE |
| K220820 | Parky App | H2o Bilisim Yazilim | Nov 17, 2022 | SESE |
| K213519 | Rune Labs Tremor Transducer System | Rune Labs, Inc. | Jun 10, 2022 | SESE |
| K211887 | Personal Kinetigraph (PKG) System Gen 2 Plus | Gkc Manufacturing Pty, Ltd. | Mar 11, 2022 | SESE |
| K161717 | Personal Kinetigraph (PKG) System | Gkc Manufacturing Pty, Ltd. | Sep 20, 2016 | SESE |
| K140086 | PERSONAL KINETIGRAPH (PKG) SYSTEM | Gkc Manufacturing Pty, Ltd. | Aug 22, 2014 | SESE |
| K063872 | KINESIA | Cleveland Medical Devices, Inc. | Apr 6, 2007 | SESE |
| K010270 | TREMOROMETER | Flexable Systems, Inc. | Jul 25, 2001 | SESE |
| K011429 | MODEL 100 ACTIVITY MONITOR | Telecom Medical, Inc. | Jul 13, 2001 | SESE |
| K971318 | MM-1 MOVEMENT MONITOR | Axon Instruments, Inc. | Jul 28, 1997 | SESE |
| K782036 | TREMOR MONITOR | Columbus Instruments Intl. Corp. | Jan 23, 1979 | SESE |
Top Applicants
- Gkc Manufacturing Pty, Ltd. — 3 clearances
- Axon Instruments, Inc. — 1 clearance
- Cleveland Medical Devices, Inc. — 1 clearance
- Columbus Instruments Intl. Corp. — 1 clearance
- Flexable Systems, Inc. — 1 clearance
