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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 / May 2026 / K260142

510(k) cleared

StimelMD (SSMD) system

Motion Informatics ltd. · May 27, 2026 · K260142

FDA cleared the StimelMD (SSMD) system from Motion Informatics ltd. on May 27, 2026 under K260142, a special 510(k). The device falls under product code IPF, Stimulator, Muscle, Powered, regulated at 21 CFR 890.5850 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Jan 20, 2026. The decision came 127 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 Motion Informatics ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260142?

K260142 is the FDA 510(k) for StimelMD (SSMD) system, submitted by Motion Informatics ltd.. FDA's decision date was May 27, 2026, under product code IPF (Stimulator, Muscle, Powered).

Who makes the StimelMD (SSMD) system?

Motion Informatics ltd., based in Yarka, is the applicant of record for K260142.

How long did the K260142 review take?

FDA received the submission on Jan 20, 2026 and issued its decision on May 27, 2026, 127 days later.

← All decisions in May 2026