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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 / June 2026 / K253257

510(k) cleared

Virgo Mobility Scooter (Virgo-D,Virgo-F)

Jiangsu Intco Medical Products Co., Ltd. · Jun 8, 2026 · K253257

FDA cleared the Virgo Mobility Scooter (Virgo-D,Virgo-F) from Jiangsu Intco Medical Products Co., Ltd. on Jun 8, 2026 under K253257, 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 Sep 29, 2025. The decision came 252 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Jiangsu Intco Medical Products Co., Ltd. has one other decision in the tracker over the last 12 months: K253241 (Electric Wheelchair (Y207BL)).

Questions & Answers

What did FDA clear under K253257?

K253257 is the FDA 510(k) for Virgo Mobility Scooter (Virgo-D,Virgo-F), submitted by Jiangsu Intco Medical Products Co., Ltd.. FDA's decision date was Jun 8, 2026, under product code INI (Vehicle, Motorized 3-Wheeled).

Who makes the Virgo Mobility Scooter (Virgo-D,Virgo-F)?

Jiangsu Intco Medical Products Co., Ltd., based in Zhenjiang, is the applicant of record for K253257.

How long did the K253257 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Jun 8, 2026, 252 days later.

← All decisions in June 2026

Sources