510(k) clearance

Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))

FDA 510(k) source

510(k) number

K261298

Applicant

Guangdong Youmeng Electrical Technology Co., Ltd.

Decision date

Aug 20, 2026

Date received

Apr 20, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

HGX

Device type

Pump, Breast, Powered

Device class

Class II

Regulation

21 CFR 884.5160

Advisory committee

Obstetrics/Gynecology

Statement or summary

Statement

Third party

N

Location

Foshan, CN