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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 / October 2025 / K252517

510(k) cleared

Manual Wheelchair (SYIV100A008)

Ningbo Shenyu Medical Equipment Co.,Ltd · Oct 3, 2025 · K252517

FDA cleared the Manual Wheelchair (SYIV100A008) from Ningbo Shenyu Medical Equipment Co.,Ltd on Oct 3, 2025 under K252517, a traditional 510(k). The device falls under product code IOR, Wheelchair, Mechanical, regulated at 21 CFR 890.3850 as a Class 1 device. The review panel was Physical Medicine.

FDA logged the submission as received on Aug 11, 2025. The decision came 53 days later, inside the 90 FDA-day goal for a 510(k).

Ningbo Shenyu Medical Equipment Co.,Ltd has one other decision in the tracker over the last 12 months: K253599 (Electric Wheelchair (W-A807, W-A807L)).

Questions & Answers

What did FDA clear under K252517?

K252517 is the FDA 510(k) for Manual Wheelchair (SYIV100A008), submitted by Ningbo Shenyu Medical Equipment Co.,Ltd. FDA's decision date was Oct 3, 2025, under product code IOR (Wheelchair, Mechanical).

Who makes the Manual Wheelchair (SYIV100A008)?

Ningbo Shenyu Medical Equipment Co.,Ltd, based in Yuyao, is the applicant of record for K252517.

How long did the K252517 review take?

FDA received the submission on Aug 11, 2025 and issued its decision on Oct 3, 2025, 53 days later.

← All decisions in October 2025

Sources