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510(k) Data Aggregation

    K Number
    K242111
    Device Name
    VIVACE
    Manufacturer
    Unimom.Co
    Date Cleared
    2025-02-06

    (202 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 VIVACE is a powered breast pump intended to express and collect milk from the breasts of lactating women. The VIVACE is intended for single user and multiple users in home and healthcare environments.
    Device Description
    The VIVACE is a powered breast pump intended to express and collect milk from the breasts of lactating women. The device is intended for daily use in a home or health care and by a single user and multiple users. VIVACE is both AC- powered battery-powered. The AC adapter uses a 100-240 VAC, 50/60Hz, 1.0A adapter, and the battery is a rechargeable Li-ion battery with specifications of 11.1V, 2200mAh, 24.4Wh. VIVACE is comprised of a flange, breast shield body, wide adapter, diaphragm cover, white valve, bottle cover, cap, disk, bottle, adapter, air tube, main body, nipple, and instruction manual. VIVACE supports a single pumping mode in which only one breast is expressed and a double pumping mode in which both breasts are expressed. The double pumping mode is divided into a synchronous mode that expresses at the same time and an alternative mode that expresses on both sides alternately. The vacuum provided covers a range of pressures from 50 mmHg, and cycle speeds (cycles/min) from 20 to 80 cycles/min. The device is provided non-sterile.
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    K Number
    K232047
    Device Name
    VIVACE
    Manufacturer
    Unimom.Co
    Date Cleared
    2024-03-28

    (262 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 VIVACE is a powered breast pump to be used by lactating women to express and collect milk from their breast. The VIVACE is intended for a single user.
    Device Description
    VIVACE is an electric breast pump intended to express and collect milk from the breasts of lactating women. The device is intended for daily use in a home environment by a single user. VIVACE is both AC-powered/battery-powered. The AC adapter uses a 100-240 V a.c, 50/60Hz, 1.0A adapter, and the battery is a rechargeable Li-ion battery with specifications of 11.1V, 2200mAh, 24.4Wh. VIVACE is comprised of a flange, breast shield body, wide adapter, diaphragm, diaphragm cover, white valve, bottle cover, cap, disk, bottle, adapter, air tube, main body, nipple, and instruction manual. VIVACE supports a single pumping mode in which only one breast is expressed and a double pumping mode in which both breasts are expressed. The double pumping mode is divided into a synchronous mode that expresses at the same time and an alternative mode that expresses on both sides alternately. The vacuum provided covers a range of pressures from 50 mmHg, and cycle speeds (cycles/min) from 20 to 80 cycles/min. The device is provided non-sterile.
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