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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 / K253064

510(k) cleared

Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air Pressure Therapy System (VU-IPC4X)

Xiamen Weiyou Intelligent Technology Co., Ltd. · Apr 30, 2026 · K253064

FDA cleared the Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air Pressure Therapy System (VU-IPC4X) from Xiamen Weiyou Intelligent Technology Co., Ltd. on Apr 30, 2026 under K253064, a traditional 510(k). The device falls under product code IRP, Massager, Powered Inflatable Tube, regulated at 21 CFR 890.5650 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Sep 22, 2025. The decision came 220 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Xiamen Weiyou Intelligent Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K253919 (Cryo And Thermo Therapy System).

Questions & Answers

What did FDA clear under K253064?

K253064 is the FDA 510(k) for Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air Pressure Therapy System (VU-IPC4X), submitted by Xiamen Weiyou Intelligent Technology Co., Ltd.. FDA's decision date was Apr 30, 2026, under product code IRP (Massager, Powered Inflatable Tube).

Who makes the Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air Pressure Therapy System (VU-IPC4X)?

Xiamen Weiyou Intelligent Technology Co., Ltd., based in Xiamen, is the applicant of record for K253064.

How long did the K253064 review take?

FDA received the submission on Sep 22, 2025 and issued its decision on Apr 30, 2026, 220 days later.

← All decisions in April 2026

Sources