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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 / K253896

510(k) cleared

TENS/EMS device (GUSE01)

Globalcare Medical Technology Co., Ltd. · Mar 4, 2026 · K253896

FDA cleared the TENS/EMS device (GUSE01) from Globalcare Medical Technology Co., Ltd. on Mar 4, 2026 under K253896, 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 Dec 5, 2025. The decision came 89 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Globalcare Medical Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253896?

K253896 is the FDA 510(k) for TENS/EMS device (GUSE01), submitted by Globalcare Medical Technology Co., Ltd.. FDA's decision date was Mar 4, 2026, under product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter).

Who makes the TENS/EMS device (GUSE01)?

Globalcare Medical Technology Co., Ltd., based in Zhongshan City, is the applicant of record for K253896.

How long did the K253896 review take?

FDA received the submission on Dec 5, 2025 and issued its decision on Mar 4, 2026, 89 days later.

← All decisions in March 2026