Electric Wheelchair (Robooter E60) (8 models)— 510(k) K240339

Name: FDA 510(k) clearance K240339
Creator: U.S. Food and Drug Administration
Published: 2024-07-22

Substantially Equivalent

Shanghai Bangbang Robotics Co., Ltd.

FDA 510(k) clearance K240339 for Electric Wheelchair (Robooter E60) (8 models), Substantially Equivalent on 2024-07-22. Applicant: Shanghai Bangbang Robotics Co., Ltd.. Device class: 2.

Clearance details

Device name as filed: Electric 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)
Applicant: Shanghai Bangbang Robotics Co., Ltd.
Product code: Code ITI
Device class: Class 2
Regulation: 21 CFR 890.3860
Advisory panel: Physical Medicine
Date received: 2024-02-05
Decision date: 2024-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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More clearances from Shanghai Bangbang Robotics Co., Ltd.

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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.