FDA 510(k)

电动轮椅（KR8803）

K号: K241588 · 2024-11-25

申请人Zhejiang Kairui Medical Device Co., Ltd.

决定日期2024-11-25

产品代码ITI

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决定实质等同

器械摘要

Electric Wheelchair (KR8803) is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Kairui Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2024-11-25 under 510(k) number K241588. 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 Electric Wheelchair (KR8803)?

Electric Wheelchair (KR8803) is a medical device that received FDA 510(k) clearance on 2024-11-25. The listed applicant is Zhejiang Kairui Medical Device Co., Ltd.. The 510(k) number is K241588.

When did Electric Wheelchair (KR8803) receive FDA 510(k) clearance?

Electric Wheelchair (KR8803) received FDA 510(k) clearance on 2024-11-25, under 510(k) number K241588.

Who is the listed applicant for Electric Wheelchair (KR8803)?

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

What is the FDA product code for Electric Wheelchair (KR8803)?

The FDA product code for Electric Wheelchair (KR8803) is ITI.

列明Zhejiang Kairui Medical Device 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。

K242791电动轮椅（KR-8807）

官方来源

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