BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EPX

    Reg #: 3030198312 · FEI: 3030198312 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    ECLOSION
    Registration Number
    3030198312
    FEI Number
    3030198312
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1029 Jonathan Ave.
    City
    Fairlawn
    State
    OH
    ZIP
    44333
    Country
    US

    Regulatory Submissions

    510(k) Number
    K892114

    Owner / Operator

    Firm Name
    Eclosion
    Operator Number
    10089589
    Address
    1029 Jonathan Ave.
    City
    Fairlawn
    State
    OH
    Postal Code
    44333
    Country
    US
    Correspondent
    Rob Ngungu

    Products

    Device Name Product Code
    Device, Biofeedback HCC

    Proprietary Names

    EPX

    Establishment Types

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