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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 / February 2026 / K253643

510(k) cleared

Mobility Scooter (S3)

Shenzhen Zhimahuaerkai Technology Co., Ltd. · Feb 18, 2026 · K253643

FDA cleared the Mobility Scooter (S3) from Shenzhen Zhimahuaerkai Technology Co., Ltd. on Feb 18, 2026 under K253643, 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 Nov 19, 2025. The decision came 91 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Shenzhen Zhimahuaerkai Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K253707 (Electric wheelchair (W1,W3)).

Questions & Answers

What did FDA clear under K253643?

K253643 is the FDA 510(k) for Mobility Scooter (S3), submitted by Shenzhen Zhimahuaerkai Technology Co., Ltd.. FDA's decision date was Feb 18, 2026, under product code INI (Vehicle, Motorized 3-Wheeled).

Who makes the Mobility Scooter (S3)?

Shenzhen Zhimahuaerkai Technology Co., Ltd., based in Shenzhen, is the applicant of record for K253643.

How long did the K253643 review take?

FDA received the submission on Nov 19, 2025 and issued its decision on Feb 18, 2026, 91 days later.

← All decisions in February 2026

Sources