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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 / June 2026 / K260425

510(k) cleared

TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)

Hivox Biotek, Inc. · Jun 16, 2026 · K260425

FDA cleared the TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) from Hivox Biotek, Inc. on Jun 16, 2026 under K260425, 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 Feb 10, 2026. The decision came 126 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 Hivox Biotek, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260425?

K260425 is the FDA 510(k) for TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237), submitted by Hivox Biotek, Inc.. FDA's decision date was Jun 16, 2026, under product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter).

Who makes the TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)?

Hivox Biotek, Inc., based in New Taipei City, is the applicant of record for K260425.

How long did the K260425 review take?

FDA received the submission on Feb 10, 2026 and issued its decision on Jun 16, 2026, 126 days later.

← All decisions in June 2026