Transducer, Tremor
Regulation 882.1950
3510(k)s in 12 months (15 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in GYD
| Company | 510(k)s | Recalls |
|---|---|---|
| Gkc Manufacturing Pty, Ltd. | 3 | 0 |
| Axon Instruments, Inc. | 1 | 0 |
| Cleveland Medical Devices, Inc. | 1 | 0 |
| Columbus Instruments Intl. Corp. | 1 | 0 |
| Empatica S.r.l. | 1 | 0 |
| Flexable Systems, Inc. | 1 | 0 |
| H2o Bilisim Yazilim | 1 | 0 |
| Kneu Health Digital , Ltd. | 1 | 0 |
| Neuhealth Digital , Ltd. | 1 | 0 |
| New Touch Digital, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 20, 2026 | K262515 | Kneu Platform (V2) Kneu Health Digital , Ltd., GB | GYD |
| Aug 14, 2026 | K260374 | Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Mon Empatica S.r.l., IT | GYD |
| Jun 17, 2026 | K253055 | Sine Monitoring Parkinsons Disease Tremor Dyskinesia Apple Watch (SMPDTDAW) Nordic Kinetics AB, SE | GYD |
| Apr 25, 2025 | K250153 | Neu Platform Neuhealth Digital , Ltd., GB | GYD |
| Mar 17, 2023 | K221772 | NeuroRPM New Touch Digital, Inc. | GYD |
| Nov 17, 2022 | K220820 | Parky App H2o Bilisim Yazilim, TR | GYD |
| Jun 10, 2022 | K213519 | Rune Labs Tremor Transducer System Rune Labs, Inc. | GYD |
| Mar 11, 2022 | K211887 | Personal Kinetigraph (PKG) System Gen 2 Plus Gkc Manufacturing Pty, Ltd., AU | GYD |
| Sep 20, 2016 | K161717 | Personal Kinetigraph (PKG) System Gkc Manufacturing Pty, Ltd., AU | GYD |
| Aug 22, 2014 | K140086 | PERSONAL KINETIGRAPH (PKG) SYSTEM Gkc Manufacturing Pty, Ltd. | GYD |
| Apr 6, 2007 | K063872 | KINESIA Cleveland Medical Devices, Inc. | GYD |
| Jul 25, 2001 | K010270 | TREMOROMETER Flexable Systems, Inc. | GYD |
| Jul 13, 2001 | K011429 | MODEL 100 ACTIVITY MONITOR Telecom Medical, Inc. | GYD |
| Jul 28, 1997 | K971318 | MM-1 MOVEMENT MONITOR Axon Instruments, Inc. | GYD |
| Jan 23, 1979 | K782036 | TREMOR MONITOR Columbus Instruments Intl. Corp. | GYD |
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