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 a medical device manufactured by Shanghai Bangbang Robotics Co., Ltd.. It received FDA 510(k) clearance on 2023-10-31 under approval 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. It is manufactured by Shanghai Bangbang Robotics Co., Ltd.. The 510(k) number is K231868.

When was Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 approved by the FDA?

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

What company makes Electric Wheelchair (Robooter E40), Model name: BBR-E40-01?

Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 is manufactured by Shanghai Bangbang Robotics Co., Ltd..

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.

Related Clinical Trials

NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT06235970 Cognitive Enhancement Through Model-based and Individualized Neurostimulation COMPLETED

Other Devices by Shanghai Bangbang Robotics Co., Ltd.

Related Devices (Code: ITI)

K161241e-fix E35/E36Alber GmbH K153636Liberator Powered Wheelchair with Solar CompanionSolar Mobilityllc K160031Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC)Sunrise Medical (Us), LLC K151717twionAlber GmbH K153543WHILL Model MWhill, Inc. K152672Cajun Commando 4x4Lil Critter, LLC

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.