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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 / November 2025 / K251856

510(k) cleared

Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4

Everyway Medical Instruments Co.,Ltd · Nov 21, 2025 · K251856

FDA cleared the Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 from Everyway Medical Instruments Co.,Ltd on Nov 21, 2025 under K251856, a special 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 Jun 17, 2025. The decision came 157 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 Everyway Medical Instruments Co.,Ltd in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251856?

K251856 is the FDA 510(k) for Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4, submitted by Everyway Medical Instruments Co.,Ltd. FDA's decision date was Nov 21, 2025, under product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter).

Who makes the Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4?

Everyway Medical Instruments Co.,Ltd, based in New Taipei City, is the applicant of record for K251856.

How long did the K251856 review take?

FDA received the submission on Jun 17, 2025 and issued its decision on Nov 21, 2025, 157 days later.

← All decisions in November 2025