FDA 510(k)

電動輪椅 - 型號 HP358E

K 號：K201855 · 2021-09-28

申請人Kunshan Hi-Fortune Health Products Co., Ltd.

決定日期2021-09-28

產品代碼ITI

諮詢委員會PM

決定相當於

器材摘要

Electrically Powered Wheelchair -Model HP358E 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 2021-09-28 under 510(k) number K201855. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Electrically Powered Wheelchair -Model HP358E?

Electrically Powered Wheelchair -Model HP358E is a medical device that received FDA 510(k) clearance on 2021-09-28. The listed applicant is Kunshan Hi-Fortune Health Products Co., Ltd.. The 510(k) number is K201855.

When did Electrically Powered Wheelchair -Model HP358E receive FDA 510(k) clearance?

Electrically Powered Wheelchair -Model HP358E received FDA 510(k) clearance on 2021-09-28, under 510(k) number K201855.

Who is the listed applicant for Electrically Powered Wheelchair -Model HP358E?

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 Electrically Powered Wheelchair -Model HP358E?

The FDA product code for Electrically Powered Wheelchair -Model HP358E is ITI.

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相關器械（代碼：ITI）

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