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FDA 510(k)

Merlexi Craft 運動輪椅系列

K 號:K240120 · 2024-07-05

決定日期2024-07-05
產品代碼IOR
諮詢委員會PM
決定相當於

器材摘要

Merlexi Craft Bariatric series of manual wheelchairs is the device name listed in this FDA 510(k) record. The listed applicant is Turbo Wheelchair Co., Inc.. It received FDA 510(k) clearance on 2024-07-05 under 510(k) number K240120. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Merlexi Craft Bariatric series of manual wheelchairs?

Merlexi Craft Bariatric series of manual wheelchairs is a medical device that received FDA 510(k) clearance on 2024-07-05. The listed applicant is Turbo Wheelchair Co., Inc.. The 510(k) number is K240120.

When did Merlexi Craft Bariatric series of manual wheelchairs receive FDA 510(k) clearance?

Merlexi Craft Bariatric series of manual wheelchairs received FDA 510(k) clearance on 2024-07-05, under 510(k) number K240120.

Who is the listed applicant for Merlexi Craft Bariatric series of manual wheelchairs?

The FDA 510(k) record lists Turbo Wheelchair Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Merlexi Craft Bariatric series of manual wheelchairs?

The FDA product code for Merlexi Craft Bariatric series of manual wheelchairs is IOR.

相關臨床試驗

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相關器械(代碼:IOR)

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係,請查閱連結的官方來源。

官方來源

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