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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 / K252688

510(k) cleared

Transcutaneous Electrical Nerve Stimulator (RJTENS-2)

Bozhou Rongjian Medical Appliance Co., Ltd. · Nov 24, 2025 · K252688

FDA cleared the Transcutaneous Electrical Nerve Stimulator (RJTENS-2) from Bozhou Rongjian Medical Appliance Co., Ltd. on Nov 24, 2025 under K252688, 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 Aug 26, 2025. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Bozhou Rongjian Medical Appliance Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252688?

K252688 is the FDA 510(k) for Transcutaneous Electrical Nerve Stimulator (RJTENS-2), submitted by Bozhou Rongjian Medical Appliance Co., Ltd.. FDA's decision date was Nov 24, 2025, under product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter).

Who makes the Transcutaneous Electrical Nerve Stimulator (RJTENS-2)?

Bozhou Rongjian Medical Appliance Co., Ltd., based in Bozhou, is the applicant of record for K252688.

How long did the K252688 review take?

FDA received the submission on Aug 26, 2025 and issued its decision on Nov 24, 2025, 90 days later.

← All decisions in November 2025