FDA 510(k)

Electric Wheelchair (Robooter E40), Model name: BBR-E40-01

K-Number: K231868 · 2023-10-31

ApplicantShanghai Bangbang Robotics Co., Ltd.

Decision Date2023-10-31

Product CodeITI

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 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 2023-10-31 under 510(k) number K231868. 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 E40), Model name: BBR-E40-01?

Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 is a medical device that received FDA 510(k) clearance on 2023-10-31. The listed applicant is Shanghai Bangbang Robotics Co., Ltd.. The 510(k) number is K231868.

When did Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 receive FDA 510(k) clearance?

Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 received FDA 510(k) clearance on 2023-10-31, under 510(k) number K231868.

Who is the listed applicant for Electric Wheelchair (Robooter E40), Model name: BBR-E40-01?

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 E40), Model name: BBR-E40-01?

The FDA product code for Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 is ITI.

Other records listing Shanghai Bangbang Robotics Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: ITI)

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Official Source

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