Proture Double Electric Breast Pump
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K162747 FDA 510(k)
- FDA Product Code
- HGX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.5160 FDA 510(k)
- Regulation Number
- 884.5160 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Powered Breast Pump (FDA classification II) designed for electric, dual-channel milk expression. It is intended to assist lactating individuals in manually extracting breast milk through motorised suction and cycle control, facilitating efficient and comfortable breastfeeding support.
The Proture Double Electric Breast Pump is supplied as a reusable, non-sterile medical device, intended for home or clinical use. It operates independently for each breast, allowing customisable vacuum levels and cycle settings. Authorised under FDA 510(k) clearance and MDR compliance, it is regulated under the Obstetrics/Gynecology specialty category (FDA K162747, registration numbers 3012298445 and others). No MRI safety or single-use specifications are indicated.
Frequently asked questions
Is the Proture Double Electric Breast Pump designed for single-use or can it be reused?
The Proture Double Electric Breast Pump is explicitly described as a reusable device. It is not intended for single-use, meaning it can be cleaned and used repeatedly for multiple lactating individuals, provided proper hygiene and maintenance protocols are followed.
What types of settings or customizations are available for vacuum levels and cycle control on this breast pump?
The Proture Double Electric Breast Pump features independent dual-channel operation, allowing customisable vacuum levels and cycle settings for each breast. This enables users to adjust suction intensity and massage cycles to match their comfort and milk expression needs.
Is the Proture Double Electric Breast Pump suitable for use in both home and clinical environments?
Yes, the Proture Double Electric Breast Pump is explicitly intended for both home and clinical use. Its design and regulatory compliance (FDA 510(k) clearance and MDR) support its versatility across these settings.
How is the sterility of the Proture Double Electric Breast Pump ensured, and is it supplied sterile?
The Proture Double Electric Breast Pump is supplied as a non-sterile device. Since it is reusable, sterility must be maintained through proper cleaning and disinfection procedures by the user before each use. The device is not pre-sterilized for single-use applications.
What regulatory pathways has the Proture Double Electric Breast Pump undergone, and what does this mean for its use?
The Proture Double Electric Breast Pump has undergone FDA 510(k) clearance and MDR compliance, confirming it meets regulatory standards for safety and performance. This means it has been evaluated by the FDA as substantially equivalent to a predicate device and complies with EU Medical Device Regulations, ensuring its suitability for use in the U.S. and EU markets.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Horigen - HORIGEN, Double Electric Breast Pump - GUANGDONG HORIGEN MOTHER & BABY PRODUCTS ..., Electric Breast Pump - Guangdong Horigen Mother & Baby Products Co., Ltd., Double Electric Breast Pump | Feeding Supplies | Baby Care & Nursery
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K162747 | Class II | Active |
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Manufacturer
- Manufacturer
- Guangdong Horigen Mother & Baby Products Co., Ltd.
Sources (2)
- FDA 510(k) K162747 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 29, 2026