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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 / K253707

510(k) cleared

Electric wheelchair (W1,W3)

Shenzhen Zhimahuaerkai Technology Co., Ltd. · Feb 24, 2026 · K253707

FDA cleared the Electric wheelchair (W1,W3) from Shenzhen Zhimahuaerkai Technology Co., Ltd. on Feb 24, 2026 under K253707, a traditional 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 Nov 24, 2025. The decision came 92 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: K253643 (Mobility Scooter (S3)).

Questions & Answers

What did FDA clear under K253707?

K253707 is the FDA 510(k) for Electric wheelchair (W1,W3), submitted by Shenzhen Zhimahuaerkai Technology Co., Ltd.. FDA's decision date was Feb 24, 2026, under product code ITI (Wheelchair, Powered).

Who makes the Electric wheelchair (W1,W3)?

Shenzhen Zhimahuaerkai Technology Co., Ltd., based in Shenzhen, is the applicant of record for K253707.

How long did the K253707 review take?

FDA received the submission on Nov 24, 2025 and issued its decision on Feb 24, 2026, 92 days later.

← All decisions in February 2026

Sources