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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 / December 2025 / K251958

510(k) cleared

VEINOPLUS Back

Dynapulse Medical · Dec 23, 2025 · K251958

FDA cleared the VEINOPLUS Back from Dynapulse Medical on Dec 23, 2025 under K251958, a traditional 510(k). The device falls under product code NUH, Stimulator, Nerve, Transcutaneous, Over-The-Counter, regulated at 21 CFR 882.5890 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Jun 25, 2025. The decision came 181 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 Dynapulse Medical in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251958?

K251958 is the FDA 510(k) for VEINOPLUS Back, submitted by Dynapulse Medical. FDA's decision date was Dec 23, 2025, under product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter).

Who makes the VEINOPLUS Back?

Dynapulse Medical, based in Minnetonka, MN, is the applicant of record for K251958.

How long did the K251958 review take?

FDA received the submission on Jun 25, 2025 and issued its decision on Dec 23, 2025, 181 days later.

← All decisions in December 2025