← Product Code [HGX](/productcode/HGX) · K262774

# Wearable breast pump (Model: XN/MD-2249BS, ZFHF) (K262774)

_Guangdong Horigen Mother & Baby Products Co., Ltd. · HGX · Sep 1, 2026 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K262774

## Device Facts

- **Applicant:** Guangdong Horigen Mother & Baby Products Co., Ltd.
- **Product Code:** [HGX](/productcode/HGX.md)
- **Decision Date:** Sep 1, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.5160
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology
- **Attributes:** 3rd-Party Reviewed

## Regulatory Identification

A powered breast pump in an electrically powered suction device used to express milk from the breast.

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**Source:** [https://fda.innolitics.com/device/K262774](https://fda.innolitics.com/device/K262774)

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