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The Tracker / August 2026 / K261354

510(k) cleared

Electric wheelchair (D03)

Foshan Sowell Medical Technology Co., Ltd. · Aug 21, 2026 · K261354

FDA cleared the Electric wheelchair (D03) from Foshan Sowell Medical Technology Co., Ltd. on Aug 21, 2026 under K261354, 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 Apr 24, 2026. The decision came 119 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 Foshan Sowell Medical Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261354?

K261354 is the FDA 510(k) for Electric wheelchair (D03), submitted by Foshan Sowell Medical Technology Co., Ltd.. FDA's decision date was Aug 21, 2026, under product code ITI (Wheelchair, Powered).

Who makes the Electric wheelchair (D03)?

Foshan Sowell Medical Technology Co., Ltd., based in Foshan, is the applicant of record for K261354.

How long did the K261354 review take?

FDA received the submission on Apr 24, 2026 and issued its decision on Aug 21, 2026, 119 days later.

← All decisions in August 2026