BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Leva Pelvic Digital Health System

    Reg #: 3026585193 · FEI: 3026585193 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    AXENA HEALTH, INC.
    Registration Number
    3026585193
    FEI Number
    3026585193
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2120 Commonwealth Ave, Suite 1
    City
    Auburndale
    State
    MA
    ZIP
    02466
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213913

    Owner / Operator

    Firm Name
    Axena Health, Inc.
    Operator Number
    10087350
    Address
    2120 Commonwealth Ave
    City
    Auburndale
    State
    MA
    Postal Code
    02466
    Country
    US

    Products

    Device Name Product Code
    Perineometer HIR

    Proprietary Names

    Leva Pelvic Digital Health System Leva Pelvic Health System Leva System Leva® Pelvic Health System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility