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FDA 510(k)

Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02)

K-Number: K253276 · 2026-01-15

ApplicantShanghai Bangbang Robotics Co., Ltd.
Decision Date2026-01-15
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02) is a medical device manufactured by Shanghai Bangbang Robotics Co., Ltd.. It received FDA 510(k) clearance on 2026-01-15 under approval number K253276. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Shanghai Bangbang Robotics Co., Ltd.. The 510(k) number is K253276.

When was Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02) approved by the FDA?

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

What company makes 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 manufactured by Shanghai Bangbang Robotics Co., Ltd..

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.

Other Devices by Shanghai Bangbang Robotics Co., Ltd.

K231868Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 K223393Electric Wheelchair K240339Electric Wheelchair (Robooter E60) (BBR-E60-01); Electric Wheelchair (Robooter E60) (BBR-E60-02); Electric Wheelchair (Robooter E60) (BBR-E60-03); Electric Wheelchair (Robooter E60) (BBR-E60-04); Electric Wheelchair (Robooter E60) (BBR-E60-05); Electric Wheelchair (Robooter E60) (BBR-E60-06); Electric Wheelchair (Robooter E60) (BBR-E60-07); Electric Wheelchair (Robooter E60) (BBR-E60-08)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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