FDA 510(k)

邊疆系列電動輪椅

K 號：K213090 · 2021-11-19

決定日期2021-11-19

產品代碼ITI

諮詢委員會PM

決定相當於

器材摘要

Frontier Series Power Wheelchairs is the device name listed in this FDA 510(k) record. The listed applicant is Magic Mobility. It received FDA 510(k) clearance on 2021-11-19 under 510(k) number K213090. 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 Frontier Series Power Wheelchairs?

Frontier Series Power Wheelchairs is a medical device that received FDA 510(k) clearance on 2021-11-19. The listed applicant is Magic Mobility. The 510(k) number is K213090.

When did Frontier Series Power Wheelchairs receive FDA 510(k) clearance?

Frontier Series Power Wheelchairs received FDA 510(k) clearance on 2021-11-19, under 510(k) number K213090.

Who is the listed applicant for Frontier Series Power Wheelchairs?

The FDA 510(k) record lists Magic Mobility as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Frontier Series Power Wheelchairs?

The FDA product code for Frontier Series Power Wheelchairs is ITI.

其他以 Magic Mobility 為申請人之記錄

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。

K233877XT系列電動輪椅 (XT2)，XT系列電動輪椅 (XT4)K211574極端 X8 K203083魔術360電動輪椅

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。

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官方來源

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