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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / January 2026 / K253276

510(k) cleared

Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02)

Shanghai Bangbang Robotics Co., Ltd. · Jan 15, 2026 · K253276

FDA cleared the Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02) from Shanghai Bangbang Robotics Co., Ltd. on Jan 15, 2026 under K253276, a special 510(k). The device falls under product code ITI, Wheelchair, Powered, regulated at 21 CFR 890.3860 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Sep 29, 2025. The decision came 108 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Shanghai Bangbang Robotics Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253276?

K253276 is the FDA 510(k) for Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02), submitted by Shanghai Bangbang Robotics Co., Ltd.. FDA's decision date was Jan 15, 2026, under product code ITI (Wheelchair, Powered).

Who makes the Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02)?

Shanghai Bangbang Robotics Co., Ltd., based in Shanghai, is the applicant of record for K253276.

How long did the K253276 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Jan 15, 2026, 108 days later.

← All decisions in January 2026