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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 / K253926

510(k) cleared

Diacore

ShenB Co., Ltd. · Apr 10, 2026 · K253926

FDA cleared the Diacore from ShenB Co., Ltd. on Apr 10, 2026 under K253926, 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 Dec 8, 2025. The decision came 123 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

ShenB Co., Ltd. has one other decision in the tracker over the last 12 months: K251649 (Sunny Plus (Sunny)).

Questions & Answers

What did FDA clear under K253926?

K253926 is the FDA 510(k) for Diacore, submitted by ShenB Co., Ltd.. FDA's decision date was Apr 10, 2026, under product code NGX (Stimulator, Muscle, Powered, For Muscle Conditioning).

Who makes the Diacore?

ShenB Co., Ltd., based in Seoul, is the applicant of record for K253926.

How long did the K253926 review take?

FDA received the submission on Dec 8, 2025 and issued its decision on Apr 10, 2026, 123 days later.

← All decisions in April 2026

Sources