Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728)— 510(k) K252744
Substantially EquivalentCixi Ruihong Electric Appliance Co., Ltd.
FDA 510(k) clearance K252744 for Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728), Substantially Equivalent on 2026-04-03. Applicant: Cixi Ruihong Electric Appliance Co., Ltd.. Device class: 2.
Summary
Cixi Ruihong Electric Appliance's Wearable Electric Breast Pump is filed under product code HGX (Pump, Breast, Powered). The name lists four models: RH 668, RH 708, RH 718, and RH 728.
Class II, 21 CFR 884.5160. Obstetrics/Gynecology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Cixi Ruihong Electric Appliance filed from Cixi, China. The record shows 217 calendar days from receipt to decision (August 29, 2025 to April 3, 2026).
Clearance details
- Applicant
- Cixi Ruihong Electric Appliance Co., Ltd.
- Product code
- Product code HGX
- Device class
- Class 2
- Regulation
- 21 CFR 884.5160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cixi, CN
Recent devices under product code HGX
view all- K262125 — Nenesupply Venus Handsfree Breast Pump (NBP001-HF)
- K261782 — MODO DUO Electric Pump (B11621, B11673)
- K254203 — Wearable Breast Pump (Model S36)
- K261622 — Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62) +1 more
- K262774 — Wearable breast pump (Model: XN/MD-2249BS, ZFHF)
More clearances from Cixi Ruihong Electric Appliance Co., Ltd.
view allAdverse events under product code HGX
product code HGX- Injury
- 758
- Other
- 2
- Total
- 760
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.