Sine Monitoring Parkinsons Disease Tremor Dyskinesia Apple Watch (SMPDTDAW)— 510(k) K253055
Substantially EquivalentNordic Kinetics AB
FDA 510(k) clearance K253055 for Sine Monitoring Parkinsons Disease Tremor Dyskinesia Apple Watch (SMPDTDAW), Substantially Equivalent on 2026-06-17. Applicant: Nordic Kinetics AB. Device class: 2.
Summary
Nordic Kinetics' device is named Sine Monitoring Parkinsons Disease Tremor Dyskinesia Apple Watch (SMPDTDAW), and it's filed under GYD, tremor transducers. Everything beyond the code name, including the disease and Apple Watch references, comes from the device name.
Class II, 21 CFR 882.1950. Neurology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Nordic Kinetics filed from Lund, Sweden. Review took 268 calendar days (September 22, 2025 to June 17, 2026).
Clearance details
- Applicant
- Nordic Kinetics AB
- Product code
- Product code GYD
- Device class
- Class 2
- Regulation
- 21 CFR 882.1950
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lund, SE
Recent devices under product code GYD
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