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FDA 510(k)

Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”)

K-Number: K253055 · 2026-06-17

ApplicantNordic Kinetics AB
Decision Date2026-06-17
Product CodeGYD
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”) is the device name listed in this FDA 510(k) record. The listed applicant is Nordic Kinetics AB. It received FDA 510(k) clearance on 2026-06-17 under 510(k) number K253055. The device is classified under product code GYD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”)?

Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”) is a medical device that received FDA 510(k) clearance on 2026-06-17. The listed applicant is Nordic Kinetics AB. The 510(k) number is K253055.

When did Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”) receive FDA 510(k) clearance?

Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”) received FDA 510(k) clearance on 2026-06-17, under 510(k) number K253055.

Who is the listed applicant for Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”)?

The FDA 510(k) record lists Nordic Kinetics AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”)?

The FDA product code for Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”) is GYD.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT03893500Utility of At-home Monitoring of Exercise Capacity by App-based 6-minute Walk TestCOMPLETEDNCT06671171Wearable Assessment of Thoracic, Cardiac Health and Exercise Performance TrialCOMPLETEDNCT07574164Closed-loop TMS for TremorRECRUITINGNCT07635823Adaptive DBS for PDRECRUITINGNCT07663799Wearable Assessment of Thoracic, Cardiac Health and Exercise Performance Trial ProspectiveNOT_YET_RECRUITING

Related Devices (Code: GYD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250153Neu PlatformNeuhealth Digital , Ltd.K221772NeuroRPMNew Touch Digital, Inc.K220820Parky AppH2o Bilisim YazilimK213519Rune Labs Tremor Transducer SystemRune Labs, Inc.K211887Personal Kinetigraph (PKG) System Gen 2 PlusGkc Manufacturing Pty, Ltd.K161717Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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