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The Tracker / September 2026 / K260144

510(k) cleared

Reclining wheelchair (YJ-013L)

Zhenjiang Assure Medical Equipment Co., Ltd. · Sep 15, 2026 · K260144

FDA cleared the Reclining wheelchair (YJ-013L) from Zhenjiang Assure Medical Equipment Co., Ltd. on Sep 15, 2026 under K260144, a special 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 Jan 20, 2026. The decision came 238 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: K261919 (Multifunctional wheelchair (YJ-059)), K260141 (Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)), 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 K260144?

K260144 is the FDA 510(k) for Reclining wheelchair (YJ-013L), submitted by Zhenjiang Assure Medical Equipment Co., Ltd.. FDA's decision date was Sep 15, 2026, under product code IOR (Wheelchair, Mechanical).

Who makes the Reclining wheelchair (YJ-013L)?

Zhenjiang Assure Medical Equipment Co., Ltd., based in Zhenjiang City, is the applicant of record for K260144.

How long did the K260144 review take?

FDA received the submission on Jan 20, 2026 and issued its decision on Sep 15, 2026, 238 days later.

← All decisions in September 2026