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FDA 510(k)

Sine 監測帕金森病震顫異常 Apple Watch （“SMPDTDAW”）

K 號：K253055 · 2026-06-17

申請人Nordic Kinetics AB
決定日期2026-06-17
產品代碼GYD
諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

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相關器械（代碼：GYD）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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