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FDA 510(k)

維洛克斯電動輪椅

K 號:K231315 · 2024-01-12

決定日期2024-01-12
產品代碼ITI
諮詢委員會PM
決定相當於

器材摘要

Velox Power Chair is the device name listed in this FDA 510(k) record. The listed applicant is Velox Manufacturing, Inc.. It received FDA 510(k) clearance on 2024-01-12 under 510(k) number K231315. 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 Velox Power Chair?

Velox Power Chair is a medical device that received FDA 510(k) clearance on 2024-01-12. The listed applicant is Velox Manufacturing, Inc.. The 510(k) number is K231315.

When did Velox Power Chair receive FDA 510(k) clearance?

Velox Power Chair received FDA 510(k) clearance on 2024-01-12, under 510(k) number K231315.

Who is the listed applicant for Velox Power Chair?

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

What is the FDA product code for Velox Power Chair?

The FDA product code for Velox Power Chair is ITI.

相關臨床試驗

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相關器械(代碼:ITI)

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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