510(k) clearance

Electric Scooter (FDB08, FDB08A, FDB12)

FDA 510(k) source

510(k) number

K261859

Applicant

Anhui JBH Medical Apparatus Co., Ltd.

Decision date

Sep 19, 2026

Date received

Jun 4, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

INI

Device type

Vehicle, Motorized 3-Wheeled

Device class

Class II

Regulation

21 CFR 890.3800

Advisory committee

Physical Medicine

Statement or summary

Summary

Third party

N

Location

Chuzhou, CN