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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 / K253740

510(k) cleared

TENS&EMS (HZ9151B, HZ9151C, HZ9151D)

Hong Qiangxing (Shenzhen) Electronics Limited · Dec 23, 2025 · K253740

FDA cleared the TENS&EMS (HZ9151B, HZ9151C, HZ9151D) from Hong Qiangxing (Shenzhen) Electronics Limited on Dec 23, 2025 under K253740, a traditional 510(k) reviewed through the Third Party Review Program. 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 Nov 24, 2025. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Hong Qiangxing (Shenzhen) Electronics Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253740?

K253740 is the FDA 510(k) for TENS&EMS (HZ9151B, HZ9151C, HZ9151D), submitted by Hong Qiangxing (Shenzhen) Electronics Limited. FDA's decision date was Dec 23, 2025, under product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter).

Who makes the TENS&EMS (HZ9151B, HZ9151C, HZ9151D)?

Hong Qiangxing (Shenzhen) Electronics Limited, based in Shenzhen, is the applicant of record for K253740.

How long did the K253740 review take?

FDA received the submission on Nov 24, 2025 and issued its decision on Dec 23, 2025, 29 days later.

← All decisions in December 2025