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The Tracker / September 2026 / K260229

510(k) cleared

Electric wheelchair (HC819N, HC830N, HC831N)

Yongkang Hengyi Vehicle Co., Ltd. · Sep 8, 2026 · K260229

FDA cleared the Electric wheelchair (HC819N, HC830N, HC831N) from Yongkang Hengyi Vehicle Co., Ltd. on Sep 8, 2026 under K260229, 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 Jan 26, 2026. The decision came 225 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 Yongkang Hengyi Vehicle Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260229?

K260229 is the FDA 510(k) for Electric wheelchair (HC819N, HC830N, HC831N), submitted by Yongkang Hengyi Vehicle Co., Ltd.. FDA's decision date was Sep 8, 2026, under product code ITI (Wheelchair, Powered).

Who makes the Electric wheelchair (HC819N, HC830N, HC831N)?

Yongkang Hengyi Vehicle Co., Ltd., based in Yongkang, is the applicant of record for K260229.

How long did the K260229 review take?

FDA received the submission on Jan 26, 2026 and issued its decision on Sep 8, 2026, 225 days later.

← All decisions in September 2026