Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”)
FDA 510(k) clearance K253055 · decided 2026-06-17
Clearance details
- K-number
- K253055
- Device name
- Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”)
- Applicant
- Nordic Kinetics AB
- Decision
- Substantially Equivalent
- Date received
- 2025-09-22
- Decision date
- 2026-06-17
- Days to decision
- 268 days
- Clearance type
- Traditional
- Product code
- GYD
- Device class
- 2
- Regulation number
- 882.1950
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Lund, SE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Neu Platform (K250153) | Neuhealth Digital , Ltd. | 2025-04-25 |
| NeuroRPM (K221772) | New Touch Digital, Inc. | 2023-03-17 |
| Parky App (K220820) | H2o Bilisim Yazilim | 2022-11-17 |
| Rune Labs Tremor Transducer System (K213519) | Rune Labs, Inc. | 2022-06-10 |
| Personal Kinetigraph (PKG) System Gen 2 Plus (K211887) | Gkc Manufacturing Pty, Ltd. | 2022-03-11 |
| Personal Kinetigraph (PKG) System (K161717) | Gkc Manufacturing Pty, Ltd. | 2016-09-20 |
| PERSONAL KINETIGRAPH (PKG) SYSTEM (K140086) | Gkc Manufacturing Pty, Ltd. | 2014-08-22 |
| KINESIA (K063872) | Cleveland Medical Devices, Inc. | 2007-04-06 |
| TREMOROMETER (K010270) | Flexable Systems, Inc. | 2001-07-25 |
| MODEL 100 ACTIVITY MONITOR (K011429) | Telecom Medical, Inc. | 2001-07-13 |
| MM-1 MOVEMENT MONITOR (K971318) | Axon Instruments, Inc. | 1997-07-28 |
| TREMOR MONITOR (K782036) | Columbus Instruments Intl. Corp. | 1979-01-23 |
Recalls involving this device
No recalls on record reference this clearance.