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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 / June 2026 / K260849

510(k) cleared

ICON 35; ICON 45; ICON 60; ICON 30FAF

Rehasense USA, Inc. · Jun 11, 2026 · K260849

FDA cleared the ICON 35; ICON 45; ICON 60; ICON 30FAF from Rehasense USA, Inc. on Jun 11, 2026 under K260849, a traditional 510(k). The device falls under product code IOR, Wheelchair, Mechanical, regulated at 21 CFR 890.3850 as a Class 1 device. The review panel was Physical Medicine.

FDA logged the submission as received on Mar 16, 2026. The decision came 87 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Rehasense USA, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260849?

K260849 is the FDA 510(k) for ICON 35; ICON 45; ICON 60; ICON 30FAF, submitted by Rehasense USA, Inc.. FDA's decision date was Jun 11, 2026, under product code IOR (Wheelchair, Mechanical).

Who makes the ICON 35; ICON 45; ICON 60; ICON 30FAF?

Rehasense USA, Inc., based in Romeoville, IL, is the applicant of record for K260849.

How long did the K260849 review take?

FDA received the submission on Mar 16, 2026 and issued its decision on Jun 11, 2026, 87 days later.

← All decisions in June 2026