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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 / K252817

510(k) cleared

Mobility Scooter (BC-MS310)

Ningbo Baichen Medical Devices Co., Ltd. · Jan 2, 2026 · K252817

FDA cleared the Mobility Scooter (BC-MS310) from Ningbo Baichen Medical Devices Co., Ltd. on Jan 2, 2026 under K252817, a traditional 510(k). The device falls under product code INI, Vehicle, Motorized 3-Wheeled, regulated at 21 CFR 890.3800 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Sep 4, 2025. The decision came 120 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 Ningbo Baichen Medical Devices Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252817?

K252817 is the FDA 510(k) for Mobility Scooter (BC-MS310), submitted by Ningbo Baichen Medical Devices Co., Ltd.. FDA's decision date was Jan 2, 2026, under product code INI (Vehicle, Motorized 3-Wheeled).

Who makes the Mobility Scooter (BC-MS310)?

Ningbo Baichen Medical Devices Co., Ltd., based in Ningbo, is the applicant of record for K252817.

How long did the K252817 review take?

FDA received the submission on Sep 4, 2025 and issued its decision on Jan 2, 2026, 120 days later.

← All decisions in January 2026