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510(k) Data Aggregation

    K Number
    K190810
    Device Name
    OPERA, OPERA eco
    Manufacturer
    Unimom Co.
    Date Cleared
    2019-08-30

    (154 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    Unimom Co.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OPERA and OPERA eco are multiple-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.
    Device Description
    The OPERA & OPERA eco are multiple-user, powered breast pumps intended to express and collect milk from the breasts of lactating women. The OPERA eco are provided non-sterile. Two models are available; Opera and Opera eco. - "OPERA" (pink color): powered by the adapter (AD/DC adapter, INPUT: AC 100 ~240V, . 50/60Hz, OUTPUT: DC14V, 2A) or by the internal battery (Rechargeable Lithium polymer battery, 11.1 V, 2200 mAh). - . "OPERA eco" (blue color): powered by the adapter (AD/DC adapter, INPUT: AC 100 ~240V, 50/60Hz, OUTPUT: DC14V, 2A). The OPERA & OPERA eco consists of a group of hardware and software components. The hardware component(s) consist of: - Opera or Opera eco pump body ● - Breast Shield Set (Breast shield, K-POP Diaphragm, Bottle Disk, Bottle Cover, Bottle ● Cap, Bottle, Nipple, White Valve, Diaphragm Cap, Air Tube Connector, Silicone Massager) - Adaptor The OPERA & OPERA eco provide the following user features: - 1) Two Modes - Massage Mode: 5 Levels - Expression Mode: 8 Levels - 2) Adjustment of vacuum level/cycles - 3) LCD Display, for user assistance/device status Principle and Theory of Operation: The Opera and Opera eco generate negative pressure on the breast and it moves diaphragm up and down to express and collect milk from the breasts of lactating women. To prevent backflow of breastmilk, Opera & Opera eco include a backflow protector on the top of breast shield. The inserted diaphragm blocks the upper side and bottom side of breast shield, which are the pathway of air and the breastmilk.
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    K Number
    K180075
    Device Name
    MINUET LCD, MINUET LCD eco
    Manufacturer
    Unimom Co.
    Date Cleared
    2018-08-06

    (208 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    Unimom Co.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MINUET LCD and MINUET LCD eco are multiple-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.
    Device Description
    The MINUET LCD and MINUET LCD eco are portable, multiple-user, powered breast pumps to be used in home or health care settings. These devices are the same, except the MINUET LCD has a rechargeable battery whereas the MINUET LCD eco does not. The devices have two major components: control unit (pump) and breast shield kit (breast shield, diaphragm, tubing, silicone massager, and bottle components). Users have the option of single or double pumping. The devices have two operating modes: massage and expression. The massage mode has seven suction levels whereas the expression mode offers nine suction levels. The vacuum strength range is 50-280 mmHq.
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