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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 / April 2026 / K253340

510(k) cleared

Electric Wheelchair (AL-208S-063)

Zhongshan A&J Medical Equipment Co., Ltd. · Apr 3, 2026 · K253340

FDA cleared the Electric Wheelchair (AL-208S-063) from Zhongshan A&J Medical Equipment Co., Ltd. on Apr 3, 2026 under K253340, 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 Sep 30, 2025. The decision came 185 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 Zhongshan A&J Medical Equipment Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253340?

K253340 is the FDA 510(k) for Electric Wheelchair (AL-208S-063), submitted by Zhongshan A&J Medical Equipment Co., Ltd.. FDA's decision date was Apr 3, 2026, under product code ITI (Wheelchair, Powered).

Who makes the Electric Wheelchair (AL-208S-063)?

Zhongshan A&J Medical Equipment Co., Ltd., based in Zhongshan, is the applicant of record for K253340.

How long did the K253340 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Apr 3, 2026, 185 days later.

← All decisions in April 2026