510(k) clearance

Multifunctional wheelchair (YJ-059)

FDA 510(k) source

510(k) number

K261919

Applicant

Zhenjiang Assure Medical Equipment Co., Ltd.

Decision date

Sep 16, 2026

Date received

Jun 9, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

IOR

Device type

Wheelchair, Mechanical

Device class

Class I

Regulation

21 CFR 890.3850

Advisory committee

Physical Medicine

Statement or summary

Summary

Third party

N

Location

Zhenjiang, CN