FDA 510(k)

镇江确保机械轮椅，型号：K1

K号: K231320 · 2023-06-05

申请人Zhenjiang Assure Medical Equipment Co., Ltd.

决定日期2023-06-05

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

Zhenjiang Assure Mechanical Wheelchair,model:K1 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 2023-06-05 under 510(k) number K231320. 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 Zhenjiang Assure Mechanical Wheelchair,model:K1?

Zhenjiang Assure Mechanical Wheelchair,model:K1 is a medical device that received FDA 510(k) clearance on 2023-06-05. The listed applicant is Zhenjiang Assure Medical Equipment Co., Ltd.. The 510(k) number is K231320.

When did Zhenjiang Assure Mechanical Wheelchair,model:K1 receive FDA 510(k) clearance?

Zhenjiang Assure Mechanical Wheelchair,model:K1 received FDA 510(k) clearance on 2023-06-05, under 510(k) number K231320.

Who is the listed applicant for Zhenjiang Assure Mechanical Wheelchair,model:K1?

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 Zhenjiang Assure Mechanical Wheelchair,model:K1?

The FDA product code for Zhenjiang Assure Mechanical Wheelchair,model:K1 is IOR.

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）K251159电动轮椅

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。