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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 / March 2026 / K253636

510(k) cleared

Zionic Pro Max (EMS)

Termosalud S.L. · Mar 12, 2026 · K253636

FDA cleared the Zionic Pro Max (EMS) from Termosalud S.L. on Mar 12, 2026 under K253636, a traditional 510(k). The device falls under product code NGX, Stimulator, Muscle, Powered, For Muscle Conditioning, regulated at 21 CFR 890.5850 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Nov 19, 2025. The decision came 113 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Termosalud S.L. has one other decision in the tracker over the last 12 months: K261473 (Chromix).

Questions & Answers

What did FDA clear under K253636?

K253636 is the FDA 510(k) for Zionic Pro Max (EMS), submitted by Termosalud S.L.. FDA's decision date was Mar 12, 2026, under product code NGX (Stimulator, Muscle, Powered, For Muscle Conditioning).

Who makes the Zionic Pro Max (EMS)?

Termosalud S.L., based in Gijon, is the applicant of record for K253636.

How long did the K253636 review take?

FDA received the submission on Nov 19, 2025 and issued its decision on Mar 12, 2026, 113 days later.

← All decisions in March 2026

Sources