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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 / December 2025 / K252825

510(k) cleared

Manual Wheelchair (W45)

Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. · Dec 5, 2025 · K252825

FDA cleared the Manual Wheelchair (W45) from Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. on Dec 5, 2025 under K252825, a traditional 510(k). The device falls under product code IOR, Wheelchair, Mechanical, regulated at 21 CFR 890.3850 as a Class 1 device. The review panel was Physical Medicine.

FDA logged the submission as received on Sep 5, 2025. The decision came 91 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. has 3 other decisions in the tracker over the last 12 months: K250964 (Protable Phlegm Suction Unit (JMA D01)), K253632 (Manual Wheelchair (W50)), K252828 (Manual Wheelchair (W47)).

Questions & Answers

What did FDA clear under K252825?

K252825 is the FDA 510(k) for Manual Wheelchair (W45), submitted by Jiangsu Jumao X-Care Medical Equipment Co., , Ltd.. FDA's decision date was Dec 5, 2025, under product code IOR (Wheelchair, Mechanical).

Who makes the Manual Wheelchair (W45)?

Jiangsu Jumao X-Care Medical Equipment Co., , Ltd., based in Danyang, is the applicant of record for K252825.

How long did the K252825 review take?

FDA received the submission on Sep 5, 2025 and issued its decision on Dec 5, 2025, 91 days later.

← All decisions in December 2025

Sources