Identifiers
- 510(k) Number
- K163136 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 Youha electric breast pump is a powered device intended to be used to express and collect milk from the human breast. It is classified as a powered breast pump under the obstetrics and gynecology medical specialty.
This device is authorized via FDA 510(k) clearance. It is manufactured by Ningbo Youhe Electrical Appliance Technology Co., Ltd.
Frequently asked questions
What is the primary purpose of the Youha electric breast pump?
This device is intended to be used to express and collect milk from the human breast. It is classified as a powered breast pump within the obstetrics and gynecology medical specialty.
Is this device authorized for use in the United States?
Yes, the Youha electric breast pump is authorized via FDA 510(k) clearance, which indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.
Who is the manufacturer of this device?
The Youha electric breast pump is manufactured by Ningbo Youhe Electrical Appliance Technology Co., Ltd., located in Cixi, China.
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: Ningbo YOUHA Electrical Technology Co., Ltd., Ningbo Youhe Electrical Appliance Technology Co., Ltd., Relaxed Life Begins with YOUHA - Official Global Website
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K163136 | Class II | Active |
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Manufacturer
Sources (1)
- FDA 510(k) K163136 24 fields · synced Sep 21, 2026