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FDA 510(k)

Power-Flex (PFX1214)；Power-Flex (PFX1517)；Power-Flex (PFX1820)

K号: K242430 · 2024-11-12

申请人Soul Mobility
决定日期2024-11-12
产品代码ITI
咨询委员会PM 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820) is the device name listed in this FDA 510(k) record. The listed applicant is Soul Mobility. It received FDA 510(k) clearance on 2024-11-12 under 510(k) number K242430. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820)?

Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820) is a medical device that received FDA 510(k) clearance on 2024-11-12. The listed applicant is Soul Mobility. The 510(k) number is K242430.

When did Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820) receive FDA 510(k) clearance?

Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820) received FDA 510(k) clearance on 2024-11-12, under 510(k) number K242430.

Who is the listed applicant for Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820)?

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

What is the FDA product code for Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820)?

The FDA product code for Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820) is ITI.

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：ITI）

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。

K262582电动轮椅（GP100）Suzhou Green Pine Medical Co., Ltd.K262054电动轮椅Yongkang Joymax Medical Technology Co., Ltd.K260053电动轮椅（OS-R-M01I）Beijing OrionStar Technology Co., Ltd.K260229电动轮椅（HC819N，HC830N，HC831N）Yongkang Hengyi Vehicle Co., Ltd.K261354电动轮椅（D03）Foshan Sowell Medical Technology Co., Ltd.K261149电动轮椅（DY611A-2，DY612A-1）Zhejiang Lumbre Electric Appliance Co., Ltd.

官方来源

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