Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K162415
    Device Name
    Spectra 9Plus
    Manufacturer
    Uzinmedicare Company
    Date Cleared
    2017-03-15

    (198 days)

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

    Uzinmedicare Company

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spectra 9Plus is a single user, powered breast pump intended to express and collect milk from the breasts of lactating women.
    Device Description
    The Spectra 9Plus is a single-user, powered breast pump intended to express and collect milk from the breasts of lactating women. The device is intended to be a single patient reusable device. The device is capable of single and dual pumping. The Spectra 9Plus is powered by a 9V DC adaptor or rechargeable Lithium ion battery. It is composed of materials commonly found in medical devices such as polypropylene, ABS, and silicone. All milk-contacting components are constructed out of food-grade materials that are compliant with 21 C.F.R. parts 174-179. The Spectra 9Plus is considered a skin-contacting device with a limited (≤24 hours) contact duration. The user employs buttons to switch from massage mode to expression mode and to control the vacuum and cycle levels within those modes. Massage mode consists of 5 suction levels and 1 cycling speed, while expression mode has 10 suction levels and 10 cycling speeds. The Spectra 9Plus is capable of providing vacuum levels from 50-270 mmHg with cycling rates up to 70 cycles per minute.
    Ask a Question

    Page 1 of 1