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The Tracker / October 2026 / K262652

510(k) cleared

Electric Wheelchair (CN501)

Zhejiang Shimo Technology Co., Ltd. · Oct 13, 2026 · K262652

FDA cleared the Electric Wheelchair (CN501) from Zhejiang Shimo Technology Co., Ltd. on Oct 13, 2026 under K262652, 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 Jul 30, 2026. The decision came 75 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Zhejiang Shimo Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262652?

K262652 is the FDA 510(k) for Electric Wheelchair (CN501), submitted by Zhejiang Shimo Technology Co., Ltd.. FDA's decision date was Oct 13, 2026, under product code ITI (Wheelchair, Powered).

Who makes the Electric Wheelchair (CN501)?

Zhejiang Shimo Technology Co., Ltd., based in Yongkang, is the applicant of record for K262652.

How long did the K262652 review take?

FDA received the submission on Jul 30, 2026 and issued its decision on Oct 13, 2026, 75 days later.

← All decisions in October 2026