BEUDAMED
    FDA Registration Active 🇺🇸 United States

    eWave

    Reg #: 3021332567 · FEI: 3021332567 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    WEARLINQ
    Registration Number
    3021332567
    FEI Number
    3021332567
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1803 Research Blvd, #600
    City
    Rockville
    State
    MD
    ZIP
    20850
    Country
    US

    Regulatory Submissions

    510(k) Number
    K214073

    Owner / Operator

    Firm Name
    WearLinq
    Operator Number
    10087780
    Address
    1803 Research Blvd, #600
    City
    Rockville
    State
    MD
    Postal Code
    20850
    Country
    US
    Correspondent
    Sean Daniel

    Products

    Device Name Product Code
    Recorder, Magnetic Tape, Medical DSH

    Proprietary Names

    eWave

    Establishment Types

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