LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K220926
    Device Name
    Spectra Wearable
    Manufacturer
    Uzinmedicare Co., Ltd.
    Date Cleared
    2022-12-12

    (256 days)

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

    Uzinmedicare Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spectra Wearable is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Spectra Wearable is intended for a single user.
    Device Description
    The SPECTRA WEARABLE is a powered breast pump that is intended to express and collect milk from the breasts of lactating women. This breast pump is intended for use by a single user and can be used to pump breast milk from a single breast (single pumping). It is designed to work in the user's bra and is battery operated so it can be used hands-free without external power cords. The device is provided non-sterile. The SPECTRA WEARABLE allows the user to adjust the vacuum levels. Two suction patterns, massage and expression mode, are pre-programmed with variable levels and cycle speeds. The subject device is powered by a rechargeable Li-polymer battery (3.7 V, 1500 mAh).
    Ask a Question

    Page 1 of 1