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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 / October 2025 / K244041

510(k) cleared

Ultrasound Therapy Workstation (XMS-UET2)

Xemis Medical Technology (Shenzhen) Co., Ltd. · Oct 7, 2025 · K244041

FDA cleared the Ultrasound Therapy Workstation (XMS-UET2) from Xemis Medical Technology (Shenzhen) Co., Ltd. on Oct 7, 2025 under K244041, a traditional 510(k). The device falls under product code IMG, Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat, regulated at 21 CFR 890.5860 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Dec 30, 2024. The decision came 281 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 Xemis Medical Technology (Shenzhen) Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K244041?

K244041 is the FDA 510(k) for Ultrasound Therapy Workstation (XMS-UET2), submitted by Xemis Medical Technology (Shenzhen) Co., Ltd.. FDA's decision date was Oct 7, 2025, under product code IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat).

Who makes the Ultrasound Therapy Workstation (XMS-UET2)?

Xemis Medical Technology (Shenzhen) Co., Ltd., based in Shenzhen, is the applicant of record for K244041.

How long did the K244041 review take?

FDA received the submission on Dec 30, 2024 and issued its decision on Oct 7, 2025, 281 days later.

← All decisions in October 2025