FDA 510(k)

シーン・モニタリング・パーキンソン病震顫不随意運動アップルウォッチ（「SMPDTDAW」）

K番号: K253055 · 2026-06-17

決定日2026-06-17

製品コードGYD

諮問委員会Please provide the source text to translate.

決定大幅同等

医療機器の概要

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.

よくある質問

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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シーン・モニタリング・パーキンソン病震顫不随意運動アップルウォッチ（「SMPDTDAW」）

医療機器の概要

よくある質問

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公式ソース