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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 / May 2026 / K260717

510(k) cleared

Mobility Scooter (Air Carbon)

Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. · May 20, 2026 · K260717

FDA cleared the Mobility Scooter (Air Carbon) from Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. on May 20, 2026 under K260717, 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 Mar 5, 2026. The decision came 76 days later, inside the 90 FDA-day goal for a 510(k).

Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K253075 (Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0)).

Questions & Answers

What did FDA clear under K260717?

K260717 is the FDA 510(k) for Mobility Scooter (Air Carbon), submitted by Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.. FDA's decision date was May 20, 2026, under product code INI (Vehicle, Motorized 3-Wheeled).

Who makes the Mobility Scooter (Air Carbon)?

Suzhou Sweetrich Vehicle Industry Technology Co., Ltd., based in Suzhou, is the applicant of record for K260717.

How long did the K260717 review take?

FDA received the submission on Mar 5, 2026 and issued its decision on May 20, 2026, 76 days later.

← All decisions in May 2026

Sources