Identifiers
- 510(k) Number
- K102600 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)
The SimplyGo Breast Pump is a powered, electric breast pump designed to express and collect milk from lactating women. Classified as a Pump, Breast, Powered, it provides mechanical suction to facilitate milk removal, supporting breastfeeding or milk storage needs. The device is intended for home or portable use, offering convenience for mothers managing milk expression outside clinical settings.
This device is supplied as a reusable, non-sterile system intended for single-user use. It operates on electrical power and includes components such as a pump unit, silicone insert, and valve system for consistent suction. The device is regulated under FDA 510(k) clearance (K102600) and falls under Device Class II, with a regulatory classification of 884.5160. Multiple model variants (e.g., 5212911) are listed, each adhering to the same regulatory framework.
Frequently asked questions
What is the SimplyGo Breast Pump designed for?
The SimplyGo Breast Pump is designed to mechanically express and collect breast milk from lactating women. It provides powered suction to facilitate milk removal, making it suitable for mothers who need to express milk at home or while traveling. This supports breastfeeding or milk storage needs outside clinical settings.
How is the SimplyGo Breast Pump supplied and intended for use?
The SimplyGo Breast Pump is supplied as a reusable system and is intended for single-user use only. It is non-sterile, meaning it is not pre-sterilized for clinical use but is safe for home use as long as proper hygiene practices are followed. The device includes components like a pump unit, silicone insert, and valve system.
Is the SimplyGo Breast Pump single-use or reusable?
The SimplyGo Breast Pump is designed for reusable use by a single individual. While the device itself is reusable, its components may require cleaning and maintenance between uses. The manufacturer recommends following the provided instructions to ensure proper hygiene and functionality.
What model variants are available for the SimplyGo Breast Pump?
The SimplyGo Breast Pump comes in multiple model variants, including the reference model 5212911. Each variant adheres to the same regulatory framework and specifications, ensuring consistency in performance and safety. The specific model number can help identify compatibility with accessories or features.
How should the SimplyGo Breast Pump be stored?
The SimplyGo Breast Pump should be stored in a clean, dry place away from direct sunlight or extreme temperatures. After use, ensure all components are thoroughly cleaned and dried to prevent bacterial growth. Store the device in its original packaging or a designated storage case to protect it from dust and damage.
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: EVENFLO SIMPLYGO MANUAL Pdf Download | ManualsLib, EVENFLO SIMPLYGO 5212911 MANUAL Pdf Download | ManualsLib, SIMPLYGO BREAST PUMP (K102600) — FDA 510(k) | Innolitics, Simplygo Breast Pump 510 (k) FDA Premarket Notification K102600 EVENFLO ..., SimplyGo Manual Breast Pump by EvenFlo
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K102600 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Evenflo Company, Inc.
Sources (1)
- FDA 510(k) K102600 24 fields · synced Oct 1, 2026