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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 / March 2026 / K252101

510(k) cleared

JWG-1

Yamaha Motor Co., Ltd. · Mar 19, 2026 · K252101

FDA cleared the JWG-1 from Yamaha Motor Co., Ltd. on Mar 19, 2026 under K252101, a traditional 510(k). The device falls under product code ITI, Wheelchair, Powered, regulated at 21 CFR 890.3860 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Jul 3, 2025. The decision came 259 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Yamaha Motor Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252101?

K252101 is the FDA 510(k) for JWG-1, submitted by Yamaha Motor Co., Ltd.. FDA's decision date was Mar 19, 2026, under product code ITI (Wheelchair, Powered).

Who makes the JWG-1?

Yamaha Motor Co., Ltd., based in Iwata City, is the applicant of record for K252101.

How long did the K252101 review take?

FDA received the submission on Jul 3, 2025 and issued its decision on Mar 19, 2026, 259 days later.

← All decisions in March 2026