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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 / April 2026 / K252334

510(k) cleared

PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)

Pontemedag · Apr 17, 2026 · K252334

FDA cleared the PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02) from Pontemedag on Apr 17, 2026 under K252334, a traditional 510(k). The device falls under product code KPI, Stimulator, Electrical, Non-Implantable, For Incontinence, regulated at 21 CFR 876.5320 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jul 28, 2025. The decision came 263 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 Pontemedag in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252334?

K252334 is the FDA 510(k) for PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02), submitted by Pontemedag. FDA's decision date was Apr 17, 2026, under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence).

Who makes the PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)?

Pontemedag, based in Arbon, is the applicant of record for K252334.

How long did the K252334 review take?

FDA received the submission on Jul 28, 2025 and issued its decision on Apr 17, 2026, 263 days later.

← All decisions in April 2026