FDA 510(k)

电动轮椅

K号: K251159 · 2025-12-22

申请人Zhenjiang Assure Medical Equipment Co., Ltd.

决定日期2025-12-22

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 wheelchair 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 2025-12-22 under 510(k) number K251159. 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 wheelchair?

Power wheelchair is a medical device that received FDA 510(k) clearance on 2025-12-22. The listed applicant is Zhenjiang Assure Medical Equipment Co., Ltd.. The 510(k) number is K251159.

When did Power wheelchair receive FDA 510(k) clearance?

Power wheelchair received FDA 510(k) clearance on 2025-12-22, under 510(k) number K251159.

Who is the listed applicant for Power wheelchair?

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 Power wheelchair?

The FDA product code for Power wheelchair is ITI.

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）K260319K5 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）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 →

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。