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FDA 510(k)

Keffort（MC-100，MC-100A）

K号: K213133 · 2022-04-13

申请人Oriental Inspiration Limited
决定日期2022-04-13
产品代码KPI
咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同

器械摘要

Keffort (MC-100, MC-100A) is the device name listed in this FDA 510(k) record. The listed applicant is Oriental Inspiration Limited. It received FDA 510(k) clearance on 2022-04-13 under 510(k) number K213133. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Keffort (MC-100, MC-100A)?

Keffort (MC-100, MC-100A) is a medical device that received FDA 510(k) clearance on 2022-04-13. The listed applicant is Oriental Inspiration Limited. The 510(k) number is K213133.

When did Keffort (MC-100, MC-100A) receive FDA 510(k) clearance?

Keffort (MC-100, MC-100A) received FDA 510(k) clearance on 2022-04-13, under 510(k) number K213133.

Who is the listed applicant for Keffort (MC-100, MC-100A)?

The FDA 510(k) record lists Oriental Inspiration Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Keffort (MC-100, MC-100A)?

The FDA product code for Keffort (MC-100, MC-100A) is KPI.

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

列明Oriental Inspiration Limited为申报人的其他记录

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。

K233046电神经肌肉刺激器，Cure TrioK212285电神经肌肉刺激器（Cure Trio MC-310 iOS，Cure Trio MC-310 Android）K170269Hee HR MiniK170260BC-001+ 粉刺净化器

相关器械（代码：KPI）

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。

K262353BTL-299-FBTL Industries, Inc.K260178盆底肌肉训练器（KM510，KM516B）Shenzhen Konmed Technology Co., Ltd.K252601盆底肌肉训练器（PC22A）；盆底肌肉训练器（PC22A-L）；盆底肌肉训练器（PC22E）；盆底肌肉训练器（PC22E-L）Hunan Accurate Bio-Medical Technology Co., Ltd.K252552Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)Shenzhen Changkun Technology Co., Ltd.K252831Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)Dolanvy (Suzhou) Medical Technology Co., Ltd.K252334PELVIPOWER盆腔功能性磁刺激(PELVIPOWER盆腔FMS)(033-0-1100-02)Pontemedag

官方来源

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