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FDA 510(k)

Sine监测帕金森病震颤运动障碍Apple Watch（“SMPDTDAW”）

K号: K253055 · 2026-06-17

申请人Nordic Kinetics AB
决定日期2026-06-17
产品代码GYD
咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同

器械摘要

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.

常见问题

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.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：GYD）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K262515Kneu平台（V2）Kneu Health Digital , Ltd.K260374帕金森病监测用Empatica健康监测平台；EmbracePlus；EmbraceMini；Empatica护理；Empatica的PKG监测器；护理门户Empatica S.r.l.K250153Neu平台Neuhealth Digital , Ltd.K221772NeuroRPMNew Touch Digital, Inc.K220820美国食品药品监督管理局（FDA）医疗器械和放射健康中心（CDRH）的使命之一是促进医疗器械创新。因此，CDRH在帮助其利益相关者（如制造商、医疗保健专业人员、患者、患者倡导者、学术界和其他政府机构）了解医疗器械的监管环境方面发挥着重要作用。这对于创新的生理闭环控制（PCLC）设备尤为重要。H2o Bilisim YazilimK213519Rune Labs 震颤传感器系统Rune Labs, Inc.

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