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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 / K253305

510(k) cleared

TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)

Shenzhen Jiantuo Electronics Co., Ltd. · Dec 31, 2025 · K253305

FDA cleared the TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) from Shenzhen Jiantuo Electronics Co., Ltd. on Dec 31, 2025 under K253305, 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 Sep 29, 2025. The decision came 93 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 Jiantuo Electronics Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253305?

K253305 is the FDA 510(k) for TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034), submitted by Shenzhen Jiantuo Electronics Co., Ltd.. FDA's decision date was Dec 31, 2025, under product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter).

Who makes the TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)?

Shenzhen Jiantuo Electronics Co., Ltd., based in Shenzhen, is the applicant of record for K253305.

How long did the K253305 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Dec 31, 2025, 93 days later.

← All decisions in December 2025