FDA 510(k)

电动轮椅，型号W3468

K号: K220207 · 2022-03-24

申请人Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

决定日期2022-03-24

产品代码INI

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

Mobility Scooter, Model W3468 is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. It received FDA 510(k) clearance on 2022-03-24 under 510(k) number K220207. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Mobility Scooter, Model W3468?

Mobility Scooter, Model W3468 is a medical device that received FDA 510(k) clearance on 2022-03-24. The listed applicant is Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. The 510(k) number is K220207.

When did Mobility Scooter, Model W3468 receive FDA 510(k) clearance?

Mobility Scooter, Model W3468 received FDA 510(k) clearance on 2022-03-24, under 510(k) number K220207.

Who is the listed applicant for Mobility Scooter, Model W3468?

FDA 510(k)记录显示，浙江英诺欧康复设备股份有限公司为申请人。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 Mobility Scooter, Model W3468?

The FDA product code for Mobility Scooter, Model W3468 is INI.

列明Zhejiang Innuovo Rehabilitation Devices 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。

K260176移动轮椅（W3483，W3483A）K260094电动轮椅（W3465，W3902（S50碳纤维））K253812电动轮椅 (W5915B, W5915C, W5915D)K260056电动轮椅 (N5515A, N5516, N5517A, N5519)K253806电动轮椅 (N5919系列)K242471电动轮椅 (W5538)

查看所有 20 个设备 →

官方来源

在 FDA 数据库中查看 →

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。