510(k) clearance

Electric wheelchair (HC819N, HC830N, HC831N)

FDA 510(k) source

510(k) number

K260229

Applicant

Yongkang Hengyi Vehicle Co., Ltd.

Decision date

Sep 8, 2026

Date received

Jan 26, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

ITI

Device type

Wheelchair, Powered

Device class

Class II

Regulation

21 CFR 890.3860

Advisory committee

Physical Medicine

Statement or summary

Statement

Third party

N

Location

Yongkang, CN