FDA 510(k)

电动轮椅, W5907 (Q50 R碳纤维)

K号: K220740 · 2022-05-12

申请人Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

决定日期2022-05-12

产品代码ITI

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决定实质等同

器械摘要

Power Wheelchair, W5907 (Q50 R Carbon) 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 2022-05-12 under 510(k) number K220740. 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 Power Wheelchair, W5907 (Q50 R Carbon)?

Power Wheelchair, W5907 (Q50 R Carbon) is a medical device that received FDA 510(k) clearance on 2022-05-12. The listed applicant is Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. The 510(k) number is K220740.

When did Power Wheelchair, W5907 (Q50 R Carbon) receive FDA 510(k) clearance?

Power Wheelchair, W5907 (Q50 R Carbon) received FDA 510(k) clearance on 2022-05-12, under 510(k) number K220740.

Who is the listed applicant for Power Wheelchair, W5907 (Q50 R Carbon)?

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 Power Wheelchair, W5907 (Q50 R Carbon)?

The FDA product code for Power Wheelchair, W5907 (Q50 R Carbon) is ITI.

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。

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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。