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FDA 510(k)

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

N.º K: K253055 · 2026-06-17

SolicitanteNordic Kinetics AB
Fecha de decisión2026-06-17
Código de productoGYD
Comité asesorNE
DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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Dispositivos relacionados (Código: GYD)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K262515Kneu Platform (V2)Kneu Health Digital , Ltd.K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care PortalEmpatica S.r.l.K250153Neu PlatformNeuhealth Digital , Ltd.K221772NeuroRPMNew Touch Digital, Inc.K220820Parky AppH2o Bilisim YazilimK213519Rune Labs Tremor Transducer SystemRune Labs, Inc.

Fuente oficial

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