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FDA 510(k)

K5 轮椅（带摆动脚踏的16英寸，带摆动脚踏的18英寸，带摆动脚踏的20英寸，带抬高脚踏的16英寸，带抬高脚踏的18英寸，带抬高脚踏的20英寸）

K号: K260319 · 2026-03-31

申请人Zhenjiang Assure Medical Equipment Co., Ltd.
决定日期2026-03-31
产品代码IOR
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

K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with swing-away footrest 16” with elevated foot rest(ELR) 18” with elevated foot rest(ELR) 20” with elevated foot rest(ELR)) is the device name listed in this FDA 510(k) record. The listed applicant is Zhenjiang Assure Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2026-03-31 under 510(k) number K260319. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with swing-away footrest 16” with elevated foot rest(ELR) 18” with elevated foot rest(ELR) 20” with elevated foot rest(ELR))?

K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with swing-away footrest 16” with elevated foot rest(ELR) 18” with elevated foot rest(ELR) 20” with elevated foot rest(ELR)) is a medical device that received FDA 510(k) clearance on 2026-03-31. The listed applicant is Zhenjiang Assure Medical Equipment Co., Ltd.. The 510(k) number is K260319.

When did K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with swing-away footrest 16” with elevated foot rest(ELR) 18” with elevated foot rest(ELR) 20” with elevated foot rest(ELR)) receive FDA 510(k) clearance?

K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with swing-away footrest 16” with elevated foot rest(ELR) 18” with elevated foot rest(ELR) 20” with elevated foot rest(ELR)) received FDA 510(k) clearance on 2026-03-31, under 510(k) number K260319.

Who is the listed applicant for K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with swing-away footrest 16” with elevated foot rest(ELR) 18” with elevated foot rest(ELR) 20” with elevated foot rest(ELR))?

FDA 510(k)记录将镇江安瑞医疗器械有限公司列为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with swing-away footrest 16” with elevated foot rest(ELR) 18” with elevated foot rest(ELR) 20” with elevated foot rest(ELR))?

The FDA product code for K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with swing-away footrest 16” with elevated foot rest(ELR) 18” with elevated foot rest(ELR) 20” with elevated foot rest(ELR)) is IOR.

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Zhenjiang Assure Medical Equipment Co., Ltd.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。

K261919多功能轮椅（YJ-059）K260144倾斜轮椅（YJ-013L）K260145YJ-K1K2 轮椅（YJ-013F）K260141减重重型轮椅（YJ-010V，YJ-010C）K251159电动轮椅K232230YJ-K1/K2 轮椅（YJ-K1F 16 NDE；YJ-K1F 16 NDS；YJ-K1F 18 NDE；YJ-K1F 18 NDS；YJ-K1F 20 NDE；YJ-K1F 20 NDS；YJ-K1F 18 NDEE；YJ-K1F 16 VDE；YJ-K1F 16 VDS；YJ-K1F 18 VDE；YJ-K1F 18 VDS；YJ-K1F 20 VDE；YJ-K1F 20 VDS；YJ-K2 16 VDFE；YJ-K2 16 VDFS；YJ-K2 18 VDFE；YJ-K2 18 VDFS；YJ-K2 20 VDFE；YJ-K2 20 VDFS；YJ-K1G 18 NFFE；YJ-K1G 18 NFFS；YJ-K2TC 16 NAFE；YJ-K2TC 18 NAFE；YJ-K2TC 20 NAFE）

查看所有 10 个设备 →

相关器械（代码：IOR）

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。

K253762ErgoSteel（ES0001/696）Strongback Mobility AG C/O Blueaudit GmbHK261919多功能轮椅（YJ-059）Zhenjiang Assure Medical Equipment Co., Ltd.K260144倾斜轮椅（YJ-013L）Zhenjiang Assure Medical Equipment Co., Ltd.K260141减重重型轮椅（YJ-010V，YJ-010C）Zhenjiang Assure Medical Equipment Co., Ltd.K260145YJ-K1K2 轮椅（YJ-013F）Zhenjiang Assure Medical Equipment Co., Ltd.K261571手动轮椅（H008，PCK7）Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

官方来源

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