510(k) clearance

Electrically Powered Wheelchair (YC-01)

FDA 510(k) source

510(k) number

K263257

Applicant

Yurob Rehabilitation Medical Co., Ltd.

Decision date

Oct 13, 2026

Date received

Sep 17, 2026

Decision

Substantially Equivalent

Clearance type

Special

Product code

ITI

Device type

Wheelchair, Powered

Device class

Class II

Regulation

21 CFR 890.3860

Advisory committee

Physical Medicine

Statement or summary

Summary

Third party

N

Location

Kunshan, CN