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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 / K260948

510(k) cleared

Air Compression Massager (EP30B001 I)

Wavepulse (Xiamen) Healthcare Technology Co., Ltd. · Jul 24, 2026 · K260948

FDA cleared the Air Compression Massager (EP30B001 I) from Wavepulse (Xiamen) Healthcare Technology Co., Ltd. on Jul 24, 2026 under K260948, 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 Mar 23, 2026. The decision came 123 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 Wavepulse (Xiamen) Healthcare Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260948?

K260948 is the FDA 510(k) for Air Compression Massager (EP30B001 I), submitted by Wavepulse (Xiamen) Healthcare Technology Co., Ltd.. FDA's decision date was Jul 24, 2026, under product code IRP (Massager, Powered Inflatable Tube).

Who makes the Air Compression Massager (EP30B001 I)?

Wavepulse (Xiamen) Healthcare Technology Co., Ltd., based in Xiamen, is the applicant of record for K260948.

How long did the K260948 review take?

FDA received the submission on Mar 23, 2026 and issued its decision on Jul 24, 2026, 123 days later.

← All decisions in July 2026