Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02)— 510(k) K253276

Substantially Equivalent

Shanghai Bangbang Robotics Co., Ltd.

FDA 510(k) clearance K253276 for Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02), Substantially Equivalent on 2026-01-15. Applicant: Shanghai Bangbang Robotics Co., Ltd..

Clearance details

Applicant: Shanghai Bangbang Robotics Co., Ltd.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2025-09-29
Decision date: 2026-01-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code ITI

product code ITI

Death: 34
Injury: 778
Malfunction: 1,085
Other: 1
Total: 1,898

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.