FDA 510(k)

攜帶式折疊電動輪椅（型號：DC01）

K 號：K212092 · 2022-05-06

申請人Anhui Jbh Medical Apparatus Co., Ltd.

決定日期2022-05-06

產品代碼ITI

諮詢委員會PM

決定相當於

器材摘要

Portable Folding Electric Wheelchair (Model: DC01) is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Jbh Medical Apparatus Co., Ltd.. It received FDA 510(k) clearance on 2022-05-06 under 510(k) number K212092. 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 Folding Electric Wheelchair (Model: DC01)?

Portable Folding Electric Wheelchair (Model: DC01) is a medical device that received FDA 510(k) clearance on 2022-05-06. The listed applicant is Anhui Jbh Medical Apparatus Co., Ltd.. The 510(k) number is K212092.

When did Portable Folding Electric Wheelchair (Model: DC01) receive FDA 510(k) clearance?

Portable Folding Electric Wheelchair (Model: DC01) received FDA 510(k) clearance on 2022-05-06, under 510(k) number K212092.

Who is the listed applicant for Portable Folding Electric Wheelchair (Model: DC01)?

FDA 510(k) 記錄將安徵Jbh醫療儀器有限公司列為申請人。這並不單獨確立該設備製造商。

What is the FDA product code for Portable Folding Electric Wheelchair (Model: DC01)?

The FDA product code for Portable Folding Electric Wheelchair (Model: DC01) is ITI.

其他以 Anhui Jbh Medical Apparatus Co., Ltd. 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。

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查看所有 11 項裝置 →

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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