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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 / March 2026 / K253936

510(k) cleared

Power Mobility Scooter (MJMA01, MJMA02)

Nanjing Mijo Technology Co., Ltd. · Mar 12, 2026 · K253936

FDA cleared the Power Mobility Scooter (MJMA01, MJMA02) from Nanjing Mijo Technology Co., Ltd. on Mar 12, 2026 under K253936, 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 Dec 9, 2025. The decision came 93 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 Nanjing Mijo Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253936?

K253936 is the FDA 510(k) for Power Mobility Scooter (MJMA01, MJMA02), submitted by Nanjing Mijo Technology Co., Ltd.. FDA's decision date was Mar 12, 2026, under product code INI (Vehicle, Motorized 3-Wheeled).

Who makes the Power Mobility Scooter (MJMA01, MJMA02)?

Nanjing Mijo Technology Co., Ltd., based in Nanjing, is the applicant of record for K253936.

How long did the K253936 review take?

FDA received the submission on Dec 9, 2025 and issued its decision on Mar 12, 2026, 93 days later.

← All decisions in March 2026