FDA 510(k)

Y207 电动轮椅

K号: K202482 · 2021-03-18

申请人Jiangsu Intco Medical Products Co., Ltd.

决定日期2021-03-18

产品代码ITI

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决定实质等同

器械摘要

Y207 Electric Wheelchair is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Intco Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2021-03-18 under 510(k) number K202482. 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 Y207 Electric Wheelchair?

Y207 Electric Wheelchair is a medical device that received FDA 510(k) clearance on 2021-03-18. The listed applicant is Jiangsu Intco Medical Products Co., Ltd.. The 510(k) number is K202482.

When did Y207 Electric Wheelchair receive FDA 510(k) clearance?

Y207 Electric Wheelchair received FDA 510(k) clearance on 2021-03-18, under 510(k) number K202482.

Who is the listed applicant for Y207 Electric Wheelchair?

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

What is the FDA product code for Y207 Electric Wheelchair?

The FDA product code for Y207 Electric Wheelchair is ITI.

列明Jiangsu Intco Medical Products 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。

K253257维吉尔移动代步车（Virgo-D，Virgo-F）K253241电动轮椅（Y207BL）

官方来源

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