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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 / K253870

510(k) cleared

Electric Wheelchair (MP148)

Suzhou Master Machinery Manufacturing Co.,Ltd · Mar 4, 2026 · K253870

FDA cleared the Electric Wheelchair (MP148) from Suzhou Master Machinery Manufacturing Co.,Ltd on Mar 4, 2026 under K253870, 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 Dec 4, 2025. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

Suzhou Master Machinery Manufacturing Co.,Ltd has one other decision in the tracker over the last 12 months: K252687 (Manual Wheelchair (HM305-Air1, HM305-Air2)).

Questions & Answers

What did FDA clear under K253870?

K253870 is the FDA 510(k) for Electric Wheelchair (MP148), submitted by Suzhou Master Machinery Manufacturing Co.,Ltd. FDA's decision date was Mar 4, 2026, under product code ITI (Wheelchair, Powered).

Who makes the Electric Wheelchair (MP148)?

Suzhou Master Machinery Manufacturing Co.,Ltd, based in Kunshan, is the applicant of record for K253870.

How long did the K253870 review take?

FDA received the submission on Dec 4, 2025 and issued its decision on Mar 4, 2026, 90 days later.

← All decisions in March 2026

Sources