Imani i2Plus Breast Pump
FDA 510(k)Class II (US FDA 510(k))
by Imani Co.
Identifiers
- 510(k) Number
- K222573 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 Imani i2Plus Breast Pump is a powered breast pump designed to assist in the expression of breast milk. It functions as a milk collection system that can be used for pumping.
This device is authorized under FDA 510K clearance. It is classified as a Class 2 powered breast pump under regulation number 884.5160.
Frequently asked questions
What is the primary function of the imani i2Plus?
The imani i2Plus is a powered breast pump designed to assist in the expression of breast milk. It functions as a milk collection system to facilitate the pumping process.
Is this device authorized for use?
Yes, the imani i2Plus Breast Pump is authorized under FDA 510K clearance. It is classified as a Class 2 powered breast pump under regulation number 884.5160.
What medical specialty is this device associated with?
The device is categorized under the Obstetrics and Gynecology medical specialty, as it is designed to assist with the physiological process of milk expression.
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 : imani i2Plus Rechargable Wearable Breast Pumps Pair ..., Amazon.com : imani i2Plus Pro iBox Breast Pump, Latest Version Three-in ..., imani i2 Plus Pro Breast Pump - Wearable, Hands-Free, Electric
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222573 | Class II | Active |
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Manufacturer
- Manufacturer
- Imani Co.
Sources (1)
- FDA 510(k) K222573 24 fields · synced Sep 26, 2026