FDA 510(k)

電動輪椅（Robooter E80）（BBR-E80-01）；電動輪椅（Robooter E80）（BBR-E80-02）

K 號：K253276 · 2026-01-15

決定日期2026-01-15

產品代碼ITI

諮詢委員會PM

決定相當於

器材摘要

Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02) is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Bangbang Robotics Co., Ltd.. It received FDA 510(k) clearance on 2026-01-15 under 510(k) number K253276. 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 (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02)?

Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02) is a medical device that received FDA 510(k) clearance on 2026-01-15. The listed applicant is Shanghai Bangbang Robotics Co., Ltd.. The 510(k) number is K253276.

When did Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02) receive FDA 510(k) clearance?

Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02) received FDA 510(k) clearance on 2026-01-15, under 510(k) number K253276.

Who is the listed applicant for Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02)?

The FDA 510(k) record lists Shanghai Bangbang Robotics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02)?

The FDA product code for Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02) is ITI.

其他以 Shanghai Bangbang Robotics 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。

K240339電動輪椅（Robooter E60）(BBR-E60-01)；電動輪椅（Robooter E60）(BBR-E60-02)；電動輪椅（Robooter E60）(BBR-E60-03)；電動輪椅（Robooter E60）(BBR-E60-04)；電動輪椅（Robooter E60）(BBR-E60-05)；電動輪椅（Robooter E60）(BBR-E60-06)；電動輪椅（Robooter E60）(BBR-E60-07)；電動輪椅（Robooter E60）(BBR-E60-08)K231868電動輪椅（Robooter E40），型號名稱：BBR-E40-01 K223393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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