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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 / K253952

510(k) cleared

Power Wheelchair (OS-R-M01S)

Beijing OrionStar Technology Co., Ltd. · Apr 7, 2026 · K253952

FDA cleared the Power Wheelchair (OS-R-M01S) from Beijing OrionStar Technology Co., Ltd. on Apr 7, 2026 under K253952, 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 Dec 10, 2025. The decision came 118 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 Beijing OrionStar Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253952?

K253952 is the FDA 510(k) for Power Wheelchair (OS-R-M01S), submitted by Beijing OrionStar Technology Co., Ltd.. FDA's decision date was Apr 7, 2026, under product code ITI (Wheelchair, Powered).

Who makes the Power Wheelchair (OS-R-M01S)?

Beijing OrionStar Technology Co., Ltd., based in Beijing, is the applicant of record for K253952.

How long did the K253952 review take?

FDA received the submission on Dec 10, 2025 and issued its decision on Apr 7, 2026, 118 days later.

← All decisions in April 2026