FDA 510(k)

代步车（型号：W3431D）

K号: K231428 · 2023-07-14

申请人Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

决定日期2023-07-14

产品代码INI

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决定实质等同

器械摘要

Mobility Scooter (Models: W3431D) 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 2023-07-14 under 510(k) number K231428. 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 (Models: W3431D)?

Mobility Scooter (Models: W3431D) is a medical device that received FDA 510(k) clearance on 2023-07-14. The listed applicant is Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. The 510(k) number is K231428.

When did Mobility Scooter (Models: W3431D) receive FDA 510(k) clearance?

Mobility Scooter (Models: W3431D) received FDA 510(k) clearance on 2023-07-14, under 510(k) number K231428.

Who is the listed applicant for Mobility Scooter (Models: W3431D)?

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 (Models: W3431D)?

The FDA product code for Mobility Scooter (Models: W3431D) 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。

K260094电动轮椅（W3465，W3902（S50碳纤维））K260176移动轮椅（W3483，W3483A）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

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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。