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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 / September 2025 / K251623

510(k) cleared

Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061)

Shenzhen Yicai Health Technology Co., Ltd. · Sep 17, 2025 · K251623

FDA cleared the Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) from Shenzhen Yicai Health Technology Co., Ltd. on Sep 17, 2025 under K251623, 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 May 28, 2025. The decision came 112 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 Shenzhen Yicai Health Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251623?

K251623 is the FDA 510(k) for Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061), submitted by Shenzhen Yicai Health Technology Co., Ltd.. FDA's decision date was Sep 17, 2025, under product code IRP (Massager, Powered Inflatable Tube).

Who makes the Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061)?

Shenzhen Yicai Health Technology Co., Ltd., based in Shenzhen, is the applicant of record for K251623.

How long did the K251623 review take?

FDA received the submission on May 28, 2025 and issued its decision on Sep 17, 2025, 112 days later.

← All decisions in September 2025