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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 / K260412

510(k) cleared

TENS 7000 Rechargeable 4 Channel (TENS 7000H)

Shenzhen Dongdixin Technology Co., Ltd. · Jun 26, 2026 · K260412

FDA cleared the TENS 7000 Rechargeable 4 Channel (TENS 7000H) from Shenzhen Dongdixin Technology Co., Ltd. on Jun 26, 2026 under K260412, 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 9, 2026. The decision came 137 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 Shenzhen Dongdixin Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260412?

K260412 is the FDA 510(k) for TENS 7000 Rechargeable 4 Channel (TENS 7000H), submitted by Shenzhen Dongdixin Technology Co., Ltd.. FDA's decision date was Jun 26, 2026, under product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter).

Who makes the TENS 7000 Rechargeable 4 Channel (TENS 7000H)?

Shenzhen Dongdixin Technology Co., Ltd., based in Shenzhen, is the applicant of record for K260412.

How long did the K260412 review take?

FDA received the submission on Feb 9, 2026 and issued its decision on Jun 26, 2026, 137 days later.

← All decisions in June 2026