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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 / K252590

510(k) cleared

Powered Mobility Scooter (PMS105, GUT177, GCAT047)

Intradin (Shanghai) Machinery Co., Ltd. · Nov 21, 2025 · K252590

FDA cleared the Powered Mobility Scooter (PMS105, GUT177, GCAT047) from Intradin (Shanghai) Machinery Co., Ltd. on Nov 21, 2025 under K252590, 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 15, 2025. The decision came 98 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 Intradin (Shanghai) Machinery Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252590?

K252590 is the FDA 510(k) for Powered Mobility Scooter (PMS105, GUT177, GCAT047), submitted by Intradin (Shanghai) Machinery Co., Ltd.. FDA's decision date was Nov 21, 2025, under product code INI (Vehicle, Motorized 3-Wheeled).

Who makes the Powered Mobility Scooter (PMS105, GUT177, GCAT047)?

Intradin (Shanghai) Machinery Co., Ltd., based in Shanghai, is the applicant of record for K252590.

How long did the K252590 review take?

FDA received the submission on Aug 15, 2025 and issued its decision on Nov 21, 2025, 98 days later.

← All decisions in November 2025