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FDA 510(k)

行走康复训练电动轮椅（ZW518）

K号: K243783 · 2025-03-12

申请人Shenzhen Zuowei Technology Co., Ltd.
决定日期2025-03-12
产品代码IPL
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

Walking rehabilitation training electric wheelchair (ZW518) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Zuowei Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-03-12 under 510(k) number K243783. The device is classified under product code IPL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Walking rehabilitation training electric wheelchair (ZW518)?

Walking rehabilitation training electric wheelchair (ZW518) is a medical device that received FDA 510(k) clearance on 2025-03-12. The listed applicant is Shenzhen Zuowei Technology Co., Ltd.. The 510(k) number is K243783.

When did Walking rehabilitation training electric wheelchair (ZW518) receive FDA 510(k) clearance?

Walking rehabilitation training electric wheelchair (ZW518) received FDA 510(k) clearance on 2025-03-12, under 510(k) number K243783.

Who is the listed applicant for Walking rehabilitation training electric wheelchair (ZW518)?

The FDA 510(k) record lists Shenzhen Zuowei Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Walking rehabilitation training electric wheelchair (ZW518)?

The FDA product code for Walking rehabilitation training electric wheelchair (ZW518) is IPL.

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：IPL）

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。

K202728Action Trackchair HawkAction Manufacturing, Inc.K203761ParaMotionPowerbasetec GmbHK191334Tek RMD (TEK 机器人移动设备) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08Matia Robotics (Us), Inc.K190682Explorer MiniPermobil ABK191874F5 躯干 VSPermobil ABK182257UPnRIDEUpnride Robotics , Ltd.

官方来源

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