Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1950](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1950) → GYD — Transducer, Tremor

# GYD · Transducer, Tremor

_Neurology · 21 CFR 882.1950 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYD

## Overview

- **Product Code:** GYD
- **Device Name:** Transducer, Tremor
- **Regulation:** [21 CFR 882.1950](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1950)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)
- **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](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYD/K250153.md) | Neu Platform | Neuhealth Digital , Ltd. | Apr 25, 2025 | SESE |
| [K221772](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYD/K221772.md) | NeuroRPM | New Touch Digital, Inc. | Mar 17, 2023 | SESE |
| [K220820](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYD/K220820.md) | Parky App | H2o Bilisim Yazilim | Nov 17, 2022 | SESE |
| [K213519](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYD/K213519.md) | Rune Labs Tremor Transducer System | Rune Labs, Inc. | Jun 10, 2022 | SESE |
| [K211887](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYD/K211887.md) | Personal Kinetigraph (PKG) System Gen 2 Plus | Gkc Manufacturing Pty, Ltd. | Mar 11, 2022 | SESE |
| [K161717](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYD/K161717.md) | Personal Kinetigraph (PKG) System | Gkc Manufacturing Pty, Ltd. | Sep 20, 2016 | SESE |
| [K140086](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYD/K140086.md) | PERSONAL KINETIGRAPH (PKG) SYSTEM | Gkc Manufacturing Pty, Ltd. | Aug 22, 2014 | SESE |
| [K063872](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYD/K063872.md) | KINESIA | Cleveland Medical Devices, Inc. | Apr 6, 2007 | SESE |
| [K010270](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYD/K010270.md) | TREMOROMETER | Flexable Systems, Inc. | Jul 25, 2001 | SESE |
| [K011429](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYD/K011429.md) | MODEL 100 ACTIVITY MONITOR | Telecom Medical, Inc. | Jul 13, 2001 | SESE |
| [K971318](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYD/K971318.md) | MM-1 MOVEMENT MONITOR | Axon Instruments, Inc. | Jul 28, 1997 | SESE |
| [K782036](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYD/K782036.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYD](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYD)

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