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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 / January 2026 / K253632

510(k) cleared

Manual Wheelchair (W50)

Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. · Jan 29, 2026 · K253632

FDA cleared the Manual Wheelchair (W50) from Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. on Jan 29, 2026 under K253632, 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 Nov 19, 2025. The decision came 71 days later, inside the 90 FDA-day goal for a 510(k).

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)), K252825 (Manual Wheelchair (W45)), K252828 (Manual Wheelchair (W47)).

Questions & Answers

What did FDA clear under K253632?

K253632 is the FDA 510(k) for Manual Wheelchair (W50), submitted by Jiangsu Jumao X-Care Medical Equipment Co., , Ltd.. FDA's decision date was Jan 29, 2026, under product code IOR (Wheelchair, Mechanical).

Who makes the Manual Wheelchair (W50)?

Jiangsu Jumao X-Care Medical Equipment Co., , Ltd., based in Danyang, is the applicant of record for K253632.

How long did the K253632 review take?

FDA received the submission on Nov 19, 2025 and issued its decision on Jan 29, 2026, 71 days later.

← All decisions in January 2026

Sources