FDA 510(k)

電動輪椅（XW-LY007）

K 號：K261164 · 2026-07-07

申請人Yongkang Ruihe Metal Product Co., Ltd.

決定日期2026-07-07

產品代碼ITI

諮詢委員會PM

決定相當於

器材摘要

Electric wheelchair (XW-LY007 ) is the device name listed in this FDA 510(k) record. The listed applicant is Yongkang Ruihe Metal Product Co., Ltd.. It received FDA 510(k) clearance on 2026-07-07 under 510(k) number K261164. 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 (XW-LY007 )?

Electric wheelchair (XW-LY007 ) is a medical device that received FDA 510(k) clearance on 2026-07-07. The listed applicant is Yongkang Ruihe Metal Product Co., Ltd.. The 510(k) number is K261164.

When did Electric wheelchair (XW-LY007 ) receive FDA 510(k) clearance?

Electric wheelchair (XW-LY007 ) received FDA 510(k) clearance on 2026-07-07, under 510(k) number K261164.

Who is the listed applicant for Electric wheelchair (XW-LY007 )?

The FDA 510(k) record lists Yongkang Ruihe Metal Product Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electric wheelchair (XW-LY007 )?

The FDA product code for Electric wheelchair (XW-LY007 ) is ITI.

其他以 Yongkang Ruihe Metal Product 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。

K261163行動輪椅（R200）

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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