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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 / July 2026 / K261163

510(k) cleared

Mobility Scooter (R200)

Yongkang Ruihe Metal Product Co., Ltd. · Jul 7, 2026 · K261163

FDA cleared the Mobility Scooter (R200) from Yongkang Ruihe Metal Product Co., Ltd. on Jul 7, 2026 under K261163, 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 Apr 9, 2026. The decision came 89 days later, inside the 90 FDA-day goal for a 510(k).

Yongkang Ruihe Metal Product Co., Ltd. has one other decision in the tracker over the last 12 months: K261164 (Electric wheelchair (XW-LY007 )).

Questions & Answers

What did FDA clear under K261163?

K261163 is the FDA 510(k) for Mobility Scooter (R200), submitted by Yongkang Ruihe Metal Product Co., Ltd.. FDA's decision date was Jul 7, 2026, under product code INI (Vehicle, Motorized 3-Wheeled).

Who makes the Mobility Scooter (R200)?

Yongkang Ruihe Metal Product Co., Ltd., based in Yongkang, is the applicant of record for K261163.

How long did the K261163 review take?

FDA received the submission on Apr 9, 2026 and issued its decision on Jul 7, 2026, 89 days later.

← All decisions in July 2026

Sources