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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 / July 2026 / K260529

510(k) cleared

Air Compression Massager (HY-1165)

Xiamen High Top Electronic Technology Co., Ltd. · Jul 27, 2026 · K260529

FDA cleared the Air Compression Massager (HY-1165) from Xiamen High Top Electronic Technology Co., Ltd. on Jul 27, 2026 under K260529, 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 Feb 17, 2026. The decision came 160 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 Xiamen High Top Electronic Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260529?

K260529 is the FDA 510(k) for Air Compression Massager (HY-1165), submitted by Xiamen High Top Electronic Technology Co., Ltd.. FDA's decision date was Jul 27, 2026, under product code IRP (Massager, Powered Inflatable Tube).

Who makes the Air Compression Massager (HY-1165)?

Xiamen High Top Electronic Technology Co., Ltd., based in Xiamen, is the applicant of record for K260529.

How long did the K260529 review take?

FDA received the submission on Feb 17, 2026 and issued its decision on Jul 27, 2026, 160 days later.

← All decisions in July 2026