FDA 510(k)

可攜式輪椅

K 號：K243970 · 2025-03-07

申請人Intradin (Shanghai) Machinery Co., Ltd.

決定日期2025-03-07

產品代碼ITI

諮詢委員會PM

決定相當於

器材摘要

Portable Wheelchair is the device name listed in this FDA 510(k) record. The listed applicant is Intradin (Shanghai) Machinery Co., Ltd.. It received FDA 510(k) clearance on 2025-03-07 under 510(k) number K243970. 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 Portable Wheelchair?

Portable Wheelchair is a medical device that received FDA 510(k) clearance on 2025-03-07. The listed applicant is Intradin (Shanghai) Machinery Co., Ltd.. The 510(k) number is K243970.

When did Portable Wheelchair receive FDA 510(k) clearance?

Portable Wheelchair received FDA 510(k) clearance on 2025-03-07, under 510(k) number K243970.

Who is the listed applicant for Portable Wheelchair?

The FDA 510(k) record lists Intradin (Shanghai) Machinery Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Portable Wheelchair?

The FDA product code for Portable Wheelchair is ITI.

其他以 Intradin (Shanghai) Machinery Co., Ltd. 為申請人之記錄

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