K240339

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)

510(k) number
K240339
Device name
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. CN
Product code
ITI — Wheelchair, Powered
Decision date
2024-07-22
Date received
2024-02-05
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Physical Medicine
510(k) Summary (official FDA PDF): K240339.pdf
Official FDA record: K240339
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.