FDA 510(k)

電動輪椅 (HC820N)

K 號：K243440 · 2024-12-19

決定日期2024-12-19

產品代碼ITI

諮詢委員會PM

決定相當於

器材摘要

Electric Wheelchair (HC820N) is the device name listed in this FDA 510(k) record. The listed applicant is Yongkang Hengyi Vehicle Co., Ltd.. It received FDA 510(k) clearance on 2024-12-19 under 510(k) number K243440. 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 Electric Wheelchair (HC820N)?

Electric Wheelchair (HC820N) is a medical device that received FDA 510(k) clearance on 2024-12-19. The listed applicant is Yongkang Hengyi Vehicle Co., Ltd.. The 510(k) number is K243440.

When did Electric Wheelchair (HC820N) receive FDA 510(k) clearance?

Electric Wheelchair (HC820N) received FDA 510(k) clearance on 2024-12-19, under 510(k) number K243440.

Who is the listed applicant for Electric Wheelchair (HC820N)?

FDA 510(k) 記錄將永康恆益汽車有限公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Electric Wheelchair (HC820N)?

The FDA product code for Electric Wheelchair (HC820N) is ITI.

其他以 Yongkang Hengyi Vehicle 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。

K260229電動輪椅（HC819N、HC830N、HC831N）

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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