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510(k) Data Aggregation

    K Number
    K251932
    Device Name
    Spectra Platinum
    Manufacturer
    Uzinmedicare Co., Ltd.
    Date Cleared
    2025-11-25

    (154 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K150476
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Spectra Platinum is a single-user, powered breast pump intended to express and collect milk from the breasts of lactating women.

    Device Description

    The Spectra Platinum is an electrically powered breast pump intended for use by lactating women to stimulate lactation and express breast milk. The device is intended for single-user, home use. Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time.

    The Spectra Platinum operate using an AC adapter (100-240V AC, 50/60Hz, DC 12V) or a rechargeable Li-Polymer battery (11.1V, 2,000mAh).

    The Spectra Platinum is comprised of the following components: Main unit, Power adapter, Tubing, Backflow protector, Wide breast shield, Milk bottle, Screw ring, Cap, Sealing cap for milk bottle, Silicone nipple, Silicone valve. The device is provided non-sterile.

    The Spectra Platinum support a single pumping mode in which only one breast is expressed and a dual pumping mode in which both breasts are expressed. The user can switch between Massage Mode and Expression Mode using designated buttons and adjust the vacuum level and cycle speed within each mode.

    Spectra Platinum includes the following features:

    • Expression can be performed on one breast only (single mode), on both sides simultaneously (dual mode).
    • Expression mode: 1-15 level (90-270 mmHg), cycle speeds (38, 42, 46, 50, 54)
    • Massage mode: 1-5 level (60-100 mmHg), cycle speeds (70, 80, 90, 100, 105)

    The Spectra Platinum operates within these specified parameters.

    When the backflow protector is assembled between the pump unit and the wide breast shield, the silicone membrane inside the backflow protector creates a hygienic barrier by preventing air and milk from flowing back into the pump unit. This not only enables safe and hygienic breast pumping, but also protects the pump unit from contamination and potential damage caused by backflow of milk.

    AI/ML Overview

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