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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 / K252829

510(k) cleared

Powered Wheelchair (PL001-9001)

Suzhou KD Intelligent Device Co., Ltd. · Nov 12, 2025 · K252829

FDA cleared the Powered Wheelchair (PL001-9001) from Suzhou KD Intelligent Device Co., Ltd. on Nov 12, 2025 under K252829, 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 Sep 5, 2025. The decision came 68 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Suzhou KD Intelligent Device Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252829?

K252829 is the FDA 510(k) for Powered Wheelchair (PL001-9001), submitted by Suzhou KD Intelligent Device Co., Ltd.. FDA's decision date was Nov 12, 2025, under product code ITI (Wheelchair, Powered).

Who makes the Powered Wheelchair (PL001-9001)?

Suzhou KD Intelligent Device Co., Ltd., based in Taicang City, is the applicant of record for K252829.

How long did the K252829 review take?

FDA received the submission on Sep 5, 2025 and issued its decision on Nov 12, 2025, 68 days later.

← All decisions in November 2025