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510(k) K253055

Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”) by Nordic Kinetics AB — Product Code GYD

K253055 is an FDA 510(k) premarket notification submitted by Nordic Kinetics AB for the device "Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”)". The FDA issued a decision of Substantially Equivalent on June 17, 2026. The device falls under product code GYD (Transducer, Tremor), a Class II device regulated under 21 CFR 882.1950.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2026
Date Received
September 22, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Tremor
Device Class
Class II
Regulation Number
882.1950
Review Panel
NE
Submission Type

Other clearances for product code GYD

  • K250153 — Neu Platform (April 25, 2025)
  • K221772 — NeuroRPM (March 17, 2023)
  • K220820 — Parky App (November 17, 2022)
  • K213519 — Rune Labs Tremor Transducer System (June 10, 2022)
  • K211887 — Personal Kinetigraph (PKG) System Gen 2 Plus (March 11, 2022)
  • K161717 — Personal Kinetigraph (PKG) System (September 20, 2016)
  • K140086 — PERSONAL KINETIGRAPH (PKG) SYSTEM (August 22, 2014)
  • K063872 — KINESIA (April 6, 2007)
  • K010270 — TREMOROMETER (July 25, 2001)
  • K011429 — MODEL 100 ACTIVITY MONITOR (July 13, 2001)

FDA data resources