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 / September 2025 / K252428

510(k) cleared

Electric Wheelchair (Model P2)

Superpi Robot Co., Ltd. · Sep 18, 2025 · K252428

FDA cleared the Electric Wheelchair (Model P2) from Superpi Robot Co., Ltd. on Sep 18, 2025 under K252428, 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 Aug 1, 2025. The decision came 48 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K252428?

K252428 is the FDA 510(k) for Electric Wheelchair (Model P2), submitted by Superpi Robot Co., Ltd.. FDA's decision date was Sep 18, 2025, under product code ITI (Wheelchair, Powered).

Who makes the Electric Wheelchair (Model P2)?

Superpi Robot Co., Ltd., based in Hangzhou, is the applicant of record for K252428.

How long did the K252428 review take?

FDA received the submission on Aug 1, 2025 and issued its decision on Sep 18, 2025, 48 days later.

← All decisions in September 2025