FDA 510(k)

电动轮椅（型号 YC-01）

K号: K253980 · 2026-03-27

申请人Yurob Rehabilitation Medical Co., Ltd.

决定日期2026-03-27

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

Electrically Powered Wheelchair (Model YC-01) is the device name listed in this FDA 510(k) record. The listed applicant is Yurob Rehabilitation Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-03-27 under 510(k) number K253980. 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 Electrically Powered Wheelchair (Model YC-01)?

Electrically Powered Wheelchair (Model YC-01) is a medical device that received FDA 510(k) clearance on 2026-03-27. The listed applicant is Yurob Rehabilitation Medical Co., Ltd.. The 510(k) number is K253980.

When did Electrically Powered Wheelchair (Model YC-01) receive FDA 510(k) clearance?

Electrically Powered Wheelchair (Model YC-01) received FDA 510(k) clearance on 2026-03-27, under 510(k) number K253980.

Who is the listed applicant for Electrically Powered Wheelchair (Model YC-01)?

The FDA 510(k) record lists Yurob Rehabilitation Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electrically Powered Wheelchair (Model YC-01)?

The FDA product code for Electrically Powered Wheelchair (Model YC-01) is ITI.

列明Yurob Rehabilitation Medical 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。

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官方来源

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