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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 / K261232

510(k) cleared

IERO Mobility Scooter (IERO-01)

Jochu Technology Co., Ltd. · Jul 14, 2026 · K261232

FDA cleared the IERO Mobility Scooter (IERO-01) from Jochu Technology Co., Ltd. on Jul 14, 2026 under K261232, a traditional 510(k). The device falls under product code INI, Vehicle, Motorized 3-Wheeled, regulated at 21 CFR 890.3800 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Apr 15, 2026. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Jochu Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261232?

K261232 is the FDA 510(k) for IERO Mobility Scooter (IERO-01), submitted by Jochu Technology Co., Ltd.. FDA's decision date was Jul 14, 2026, under product code INI (Vehicle, Motorized 3-Wheeled).

Who makes the IERO Mobility Scooter (IERO-01)?

Jochu Technology Co., Ltd., based in Hsin Chu, is the applicant of record for K261232.

How long did the K261232 review take?

FDA received the submission on Apr 15, 2026 and issued its decision on Jul 14, 2026, 90 days later.

← All decisions in July 2026