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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 / October 2025 / K252502

510(k) cleared

Folding Mobility Scooter (KD101)

Nanjing Kangni Smart Technology Co., Ltd. · Oct 6, 2025 · K252502

FDA cleared the Folding Mobility Scooter (KD101) from Nanjing Kangni Smart Technology Co., Ltd. on Oct 6, 2025 under K252502, a traditional 510(k). The device falls under product code INI, Vehicle, Motorized 3-Wheeled, regulated at 21 CFR 890.3800 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Aug 8, 2025. The decision came 59 days later, inside the 90 FDA-day goal for a 510(k).

Nanjing Kangni Smart Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K252494 (Electrically powered wheelchair (KZ301B)).

Questions & Answers

What did FDA clear under K252502?

K252502 is the FDA 510(k) for Folding Mobility Scooter (KD101), submitted by Nanjing Kangni Smart Technology Co., Ltd.. FDA's decision date was Oct 6, 2025, under product code INI (Vehicle, Motorized 3-Wheeled).

Who makes the Folding Mobility Scooter (KD101)?

Nanjing Kangni Smart Technology Co., Ltd., based in Nanjing, is the applicant of record for K252502.

How long did the K252502 review take?

FDA received the submission on Aug 8, 2025 and issued its decision on Oct 6, 2025, 59 days later.

← All decisions in October 2025

Sources