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 / K253075

510(k) cleared

Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0)

Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. · Jan 9, 2026 · K253075

FDA cleared the Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0) from Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. on Jan 9, 2026 under K253075, 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 23, 2025. The decision came 108 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K260717 (Mobility Scooter (Air Carbon)).

Questions & Answers

What did FDA clear under K253075?

K253075 is the FDA 510(k) for Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0), submitted by Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.. FDA's decision date was Jan 9, 2026, under product code INI (Vehicle, Motorized 3-Wheeled).

Who makes the Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0)?

Suzhou Sweetrich Vehicle Industry Technology Co., Ltd., based in Suzhou, is the applicant of record for K253075.

How long did the K253075 review take?

FDA received the submission on Sep 23, 2025 and issued its decision on Jan 9, 2026, 108 days later.

← All decisions in January 2026

Sources