FDA 510(k)

HP458E 电动轮椅

K号: K212503 · 2022-01-18

申请人Kunshan Hi-Fortune Health Products Co., Ltd.

决定日期2022-01-18

产品代码ITI

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决定实质等同

器械摘要

HP458E Electrically Powered Wheelchair is the device name listed in this FDA 510(k) record. The listed applicant is Kunshan Hi-Fortune Health Products Co., Ltd.. It received FDA 510(k) clearance on 2022-01-18 under 510(k) number K212503. 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 HP458E Electrically Powered Wheelchair?

HP458E Electrically Powered Wheelchair is a medical device that received FDA 510(k) clearance on 2022-01-18. The listed applicant is Kunshan Hi-Fortune Health Products Co., Ltd.. The 510(k) number is K212503.

When did HP458E Electrically Powered Wheelchair receive FDA 510(k) clearance?

HP458E Electrically Powered Wheelchair received FDA 510(k) clearance on 2022-01-18, under 510(k) number K212503.

Who is the listed applicant for HP458E Electrically Powered Wheelchair?

The FDA 510(k) record lists Kunshan Hi-Fortune Health Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HP458E Electrically Powered Wheelchair?

The FDA product code for HP458E Electrically Powered Wheelchair is ITI.

列明Kunshan Hi-Fortune Health 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。

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