WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / January 2026 / K252275

510(k) cleared

Electric Scooter (DDF100)

Zhejiang Nysin Medical Co., Ltd. · Jan 29, 2026 · K252275

FDA cleared the Electric Scooter (DDF100) from Zhejiang Nysin Medical Co., Ltd. on Jan 29, 2026 under K252275, 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 Jul 22, 2025. The decision came 191 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 Zhejiang Nysin Medical Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252275?

K252275 is the FDA 510(k) for Electric Scooter (DDF100), submitted by Zhejiang Nysin Medical Co., Ltd.. FDA's decision date was Jan 29, 2026, under product code INI (Vehicle, Motorized 3-Wheeled).

Who makes the Electric Scooter (DDF100)?

Zhejiang Nysin Medical Co., Ltd., based in Jinhua, is the applicant of record for K252275.

How long did the K252275 review take?

FDA received the submission on Jul 22, 2025 and issued its decision on Jan 29, 2026, 191 days later.

← All decisions in January 2026