FDA 510(k)

电动轮椅（Robooter E80）（BBR-E80-01）；电动轮椅（Robooter E80）（BBR-E80-02）

K号: K253276 · 2026-01-15

决定日期2026-01-15

产品代码ITI

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决定实质等同

器械摘要

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.

常见问题

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.

列明Shanghai Bangbang Robotics Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K240339电动轮椅（Robooter E60）（BBR-E60-01）；电动轮椅（Robooter E60）（BBR-E60-02）；电动轮椅（Robooter E60）（BBR-E60-03）；电动轮椅（Robooter E60）（BBR-E60-04）；电动轮椅（Robooter E60）（BBR-E60-05）；电动轮椅（Robooter E60）（BBR-E60-06）；电动轮椅（Robooter E60）（BBR-E60-07）；电动轮椅（Robooter E60）（BBR-E60-08）K231868电动轮椅（Robooter E40），型号名称：BBR-E40-01 K223393电动轮椅

官方来源

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