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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 / K252154

510(k) cleared

Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)

Guangzhou Longest Medical Technology Co., Ltd. · Dec 9, 2025 · K252154

FDA cleared the Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) from Guangzhou Longest Medical Technology Co., Ltd. on Dec 9, 2025 under K252154, 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 Jul 9, 2025. The decision came 153 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Guangzhou Longest Medical Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K250242 (Compression Therapy Device (LGT-2202DVT)).

Questions & Answers

What did FDA clear under K252154?

K252154 is the FDA 510(k) for Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP), submitted by Guangzhou Longest Medical Technology Co., Ltd.. FDA's decision date was Dec 9, 2025, under product code NGX (Stimulator, Muscle, Powered, For Muscle Conditioning).

Who makes the Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)?

Guangzhou Longest Medical Technology Co., Ltd., based in Guangzhou, is the applicant of record for K252154.

How long did the K252154 review take?

FDA received the submission on Jul 9, 2025 and issued its decision on Dec 9, 2025, 153 days later.

← All decisions in December 2025

Sources