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The Tracker / September 2026 / K261919

510(k) cleared

Multifunctional wheelchair (YJ-059)

Zhenjiang Assure Medical Equipment Co., Ltd. · Sep 16, 2026 · K261919

FDA cleared the Multifunctional wheelchair (YJ-059) from Zhenjiang Assure Medical Equipment Co., Ltd. on Sep 16, 2026 under K261919, a traditional 510(k). The device falls under product code IOR, Wheelchair, Mechanical, regulated at 21 CFR 890.3850 as a Class 1 device. The review panel was Physical Medicine.

FDA logged the submission as received on Jun 9, 2026. The decision came 99 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Zhenjiang Assure Medical Equipment Co., Ltd. has 5 other decisions in the tracker over the last 12 months: K260141 (Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)), K260144 (Reclining wheelchair (YJ-013L)), K260145 (YJ-K1K2 Wheelchair (YJ-013F)), K260319 (K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with swing-away footrest 16 with elevated foot rest(ELR) 18 with elevated foot rest(ELR) 20 with elevated foot rest(ELR))).

Questions & Answers

What did FDA clear under K261919?

K261919 is the FDA 510(k) for Multifunctional wheelchair (YJ-059), submitted by Zhenjiang Assure Medical Equipment Co., Ltd.. FDA's decision date was Sep 16, 2026, under product code IOR (Wheelchair, Mechanical).

Who makes the Multifunctional wheelchair (YJ-059)?

Zhenjiang Assure Medical Equipment Co., Ltd., based in Zhenjiang, is the applicant of record for K261919.

How long did the K261919 review take?

FDA received the submission on Jun 9, 2026 and issued its decision on Sep 16, 2026, 99 days later.

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