DeviceClearance

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))— 510(k) K260319

Substantially Equivalent

Zhenjiang Assure Medical Equipment Co., Ltd.

FDA 510(k) clearance K260319 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)), Substantially Equivalent on 2026-03-31. Applicant: Zhenjiang Assure Medical Equipment Co., Ltd.. Device class: 1.

Summary

Zhenjiang Assure Medical Equipment's K5 wheelchair is filed under IOR, mechanical wheelchairs. The name lists six configurations: 16, 18 and 20 with a swing-away footrest, and 16, 18 and 20 with an elevated foot rest (ELR).

Class I, 21 CFR 890.3850. Physical Medicine is both the classification panel and the review panel. It was a Traditional 510(k).

Zhenjiang Assure Medical Equipment filed from Zhenjiang, China. The decision came 60 calendar days after receipt (January 30 to March 31, 2026).

Clearance details

Applicant
Zhenjiang Assure Medical Equipment Co., Ltd.
Product code
Product code IOR
Device class
Class 1
Regulation
21 CFR 890.3850
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Zhenjiang, CN
Download summary PDFView on FDA.gov ↗

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More clearances from Zhenjiang Assure Medical Equipment Co., Ltd.

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Adverse events under product code IOR

product code IOR
Death
10
Injury
232
Other
2
Total
244

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.