Identifiers
- 510(k) Number
- K201152 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)
An electric breast pump is a powered device designed to extract breast milk. It is classified as a Class II medical device under FDA regulation number 884.5160 and is substantially equivalent to a legally marketed predicate device.
The device is supplied non-sterile and intended for reuse after appropriate cleaning and disinfection. It is used in home or clinical settings for lactation support and is not indicated for MRI environments. No specific sizes, storage conditions, or additional authorizations beyond the FDA 510(k) clearance are provided in the data.
Frequently asked questions
What is the electric breast pump used for?
The electric breast pump is a powered device designed to extract breast milk and is used in home or clinical settings for lactation support, as it assists in milk expression for feeding or relief.
Is the electric breast pump sterile when supplied, and can it be reused?
The device is supplied non-sterile and is intended for reuse after appropriate cleaning and disinfection, meaning users must follow proper hygiene procedures between uses to maintain safety and functionality.
What regulatory pathway was used for this electric breast pump?
The device received FDA 510(k) clearance, indicating it is substantially equivalent to a legally marketed predicate device under regulation number 884.5160 for Class II medical devices.
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: Guangdong Horigen Mother & Baby Products Co.,Ltd., Horigen - HORIGEN, Electric Breast Pump - Guangdong Horigen Mother & Baby Products Co., Ltd., 2026 Feeding Supplies - GUANGDONG HORIGEN MOTHER & BABY PRODUCTS CO ..., Guangdong Horigen Mother & Baby Products Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201152 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Guangdong Horigen Mother & Baby Products Co., Ltd.
Sources (1)
- FDA 510(k) K201152 24 fields · synced Oct 6, 2026