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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 / K252671

510(k) cleared

Electric wheelchair (NSDS-01)

Hebei Dansong Medical Technology Co., Ltd. · Nov 3, 2025 · K252671

FDA cleared the Electric wheelchair (NSDS-01) from Hebei Dansong Medical Technology Co., Ltd. on Nov 3, 2025 under K252671, a traditional 510(k). The device falls under product code ITI, Wheelchair, Powered, regulated at 21 CFR 890.3860 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Aug 25, 2025. The decision came 70 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Hebei Dansong Medical Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252671?

K252671 is the FDA 510(k) for Electric wheelchair (NSDS-01), submitted by Hebei Dansong Medical Technology Co., Ltd.. FDA's decision date was Nov 3, 2025, under product code ITI (Wheelchair, Powered).

Who makes the Electric wheelchair (NSDS-01)?

Hebei Dansong Medical Technology Co., Ltd., based in Shijiazhuang, is the applicant of record for K252671.

How long did the K252671 review take?

FDA received the submission on Aug 25, 2025 and issued its decision on Nov 3, 2025, 70 days later.

← All decisions in November 2025