Transducer, Tremor
The Tremor Transducer is a diagnostic device used to detect, measure, and characterize involuntary tremor movements in patients with neurological conditions such as Parkinson's disease or essential tremor, converting mechanical motion into electrical signals for analysis. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is GYD under regulation 21 CFR 882.1950 in the Neurology specialty. It is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- GYD
- Device Class
- FDA class 2
- Regulation Number
- 882.1950
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K253055 | Sine Monitoring Parkinsons Disease Tremor Dyskinesia Apple Watch (SMPDTDAW) | Jun 17, 2026 | Substantially Equivalent | Nordic Kinetics AB |
| K250153 | Neu Platform | Apr 25, 2025 | Substantially Equivalent | Neuhealth Digital , Ltd. |
| K221772 | NeuroRPM | Mar 17, 2023 | Substantially Equivalent | New Touch Digital, Inc. |
| K220820 | Parky App | Nov 17, 2022 | Substantially Equivalent | H2o Bilisim Yazilim |
| K213519 | Rune Labs Tremor Transducer System | Jun 10, 2022 | Substantially Equivalent | Rune Labs, Inc. |
| K211887 | Personal Kinetigraph (PKG) System Gen 2 Plus | Mar 11, 2022 | Substantially Equivalent | Gkc Manufacturing Pty, Ltd. |
| K161717 | Personal Kinetigraph (PKG) System | Sep 20, 2016 | Substantially Equivalent | Gkc Manufacturing Pty, Ltd. |
| K140086 | PERSONAL KINETIGRAPH (PKG) SYSTEM | Aug 22, 2014 | Substantially Equivalent | Gkc Manufacturing Pty, Ltd. |
| K063872 | KINESIA | Apr 06, 2007 | Substantially Equivalent | Cleveland Medical Devices, Inc. |
| K010270 | TREMOROMETER | Jul 25, 2001 | Substantially Equivalent | Flexable Systems, Inc. |
| K011429 | MODEL 100 ACTIVITY MONITOR | Jul 13, 2001 | Substantially Equivalent | Telecom Medical, Inc. |
| K971318 | MM-1 MOVEMENT MONITOR | Jul 28, 1997 | Substantially Equivalent | Axon Instruments, Inc. |
| K782036 | TREMOR MONITOR | Jan 23, 1979 | Substantially Equivalent | Columbus Instruments Intl. Corp. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.