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 / July 2026 / K252370

510(k) cleared

GEN 4 JOY Wheelchair

Free Wheelchair Mission · Jul 24, 2026 · K252370

FDA cleared the GEN 4 JOY Wheelchair from Free Wheelchair Mission on Jul 24, 2026 under K252370, 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 Jul 30, 2025. The decision came 359 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 Free Wheelchair Mission in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252370?

K252370 is the FDA 510(k) for GEN 4 JOY Wheelchair, submitted by Free Wheelchair Mission. FDA's decision date was Jul 24, 2026, under product code IOR (Wheelchair, Mechanical).

Who makes the GEN 4 JOY Wheelchair?

Free Wheelchair Mission, based in Irvine, CA, is the applicant of record for K252370.

How long did the K252370 review take?

FDA received the submission on Jul 30, 2025 and issued its decision on Jul 24, 2026, 359 days later.

← All decisions in July 2026