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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 / November 2025 / K250576

510(k) cleared

Flexx Junior (FLX-J00, FLX-J50)

Karma Mobility Co, Ltd. · Nov 4, 2025 · K250576

FDA cleared the Flexx Junior (FLX-J00, FLX-J50) from Karma Mobility Co, Ltd. on Nov 4, 2025 under K250576, 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 Feb 27, 2025. The decision came 250 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 Karma Mobility Co, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250576?

K250576 is the FDA 510(k) for Flexx Junior (FLX-J00, FLX-J50), submitted by Karma Mobility Co, Ltd.. FDA's decision date was Nov 4, 2025, under product code IOR (Wheelchair, Mechanical).

Who makes the Flexx Junior (FLX-J00, FLX-J50)?

Karma Mobility Co, Ltd., based in Khamthleso, is the applicant of record for K250576.

How long did the K250576 review take?

FDA received the submission on Feb 27, 2025 and issued its decision on Nov 4, 2025, 250 days later.

← All decisions in November 2025