Smart Double Sides Wearable Breast Pump Electric Bilateral Breast Pump
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K230102 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 Smart Double Sides Wearable Breast Pump is a powered breast pump designed to express milk from the breast. It features two modes, Stimulation Mode and Expression Mode, with nine adjustable levels to provide a customized pumping experience.
This device is supplied as a wearable, wireless unit intended for use at home or on the go. It is regulated as a Class 2 medical device under FDA 510(k) clearance.
Frequently asked questions
What is the primary purpose of the Smart Double Sides Wearable Breast Pump?
This device is a powered breast pump intended to express milk from the breast. It is designed to provide a customized pumping experience through two distinct modes, Stimulation and Expression, each offering nine adjustable levels.
How is this breast pump designed for use?
The pump is supplied as a wearable, wireless unit. This design is intended to provide convenience for users who need to express milk while at home or while on the go.
What is the regulatory status of this device?
The Smart Double Sides Wearable Breast Pump is regulated as a Class 2 medical device. It has received FDA 510(k) clearance under the regulation number 884.5160.
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: Amazon.com : Smart Double Sides Wearable Breast Pump, Electric ..., Smart Double Sides Wearable Breast Pump, Electric Bilateral Breast Pump, Smart double sides wearable breast pump, Electric bilateral breast pump ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230102 | Class II | Active |
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Manufacturer
- Manufacturer
- Huizhou LVB Maternal & Infant Supplies Co., Ltd.
- FDA Applicant
- Huizhou Lvb Maternal and Infant Supplies Co., Ltd.
Sources (1)
- FDA 510(k) K230102 24 fields · synced Oct 6, 2026