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The Tracker / March 2026 / K260319

510(k) cleared

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))

Zhenjiang Assure Medical Equipment Co., Ltd. · Mar 31, 2026 · K260319

FDA cleared the 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)) from Zhenjiang Assure Medical Equipment Co., Ltd. on Mar 31, 2026 under K260319, 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 Jan 30, 2026. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).

Zhenjiang Assure Medical Equipment Co., Ltd. has one other decision in the tracker over the last 12 months: K251159 (Power wheelchair).

Questions & Answers

What did FDA clear under K260319?

K260319 is the FDA 510(k) for 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)), submitted by Zhenjiang Assure Medical Equipment Co., Ltd.. FDA's decision date was Mar 31, 2026, under product code IOR (Wheelchair, Mechanical).

Who makes the 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))?

Zhenjiang Assure Medical Equipment Co., Ltd., based in Zhenjiang, is the applicant of record for K260319.

How long did the K260319 review take?

FDA received the submission on Jan 30, 2026 and issued its decision on Mar 31, 2026, 60 days later.

← All decisions in March 2026

Sources