FDA 510(k)

Invacare AVIVA 風暴 RX 電動輪椅

K 號：K202379 · 2021-03-19

決定日期2021-03-19

產品代碼ITI

諮詢委員會PM

決定相當於

器材摘要

Invacare AVIVA Storm RX Power Chair is the device name listed in this FDA 510(k) record. The listed applicant is Invacare Corporation. It received FDA 510(k) clearance on 2021-03-19 under 510(k) number K202379. 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 Invacare AVIVA Storm RX Power Chair?

Invacare AVIVA Storm RX Power Chair is a medical device that received FDA 510(k) clearance on 2021-03-19. The listed applicant is Invacare Corporation. The 510(k) number is K202379.

When did Invacare AVIVA Storm RX Power Chair receive FDA 510(k) clearance?

Invacare AVIVA Storm RX Power Chair received FDA 510(k) clearance on 2021-03-19, under 510(k) number K202379.

Who is the listed applicant for Invacare AVIVA Storm RX Power Chair?

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

What is the FDA product code for Invacare AVIVA Storm RX Power Chair?

The FDA product code for Invacare AVIVA Storm RX Power Chair is ITI.

其他以 Invacare Corporation 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。

K203210Invacare 銀河5NXG 氧氣濃縮機 K200890Invacare 完美2V 氧氣濃縮機 K192216Invacare AVIVA FX 電動輪椅，型號：IFX-20MP K191159單電池組濃縮器，配備可攜帶背包和肩帶，A型，POC1 USB 藍牙擴充棒，POC1 Invacare 移動醫療應用附加設備，適用於 iOS 和 Android 裝置，Invacare 銀河系移動氧濃縮器，具連接功能 K182946Invacare TDX SP2-HD 配有船長座椅 K181090Invacare® Solara® 3G 及 Solara® 3G Spree 手動輪椅手冊

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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。

K262582電動輪椅（GP100）Suzhou Green Pine Medical Co., Ltd.K262054電動輪椅Yongkang Joymax Medical Technology Co., Ltd.K260053電動輪椅 (OS-R-M01I)Beijing OrionStar Technology Co., Ltd.K260229電動輪椅（HC819N、HC830N、HC831N）Yongkang Hengyi Vehicle Co., Ltd.K261354電動輪椅（D03）Foshan Sowell Medical Technology Co., Ltd.K261149電動輪椅（DY611A-2，DY612A-1）Zhejiang Lumbre Electric Appliance Co., Ltd.

官方來源

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