BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Body Armor PFA Walker

    Reg #: 1122845 · FEI: 1000123428 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    13
    Establishment Types
    4
    Classifications
    1

    Registration Details

    Registration Name
    DARCO INTERNATIONAL, INC.
    Registration Number
    1122845
    FEI Number
    1000123428
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    810 MEMORIAL BLVD.
    City
    HUNTINGTON
    State
    WV
    ZIP
    25701
    Country
    US

    Owner / Operator

    Firm Name
    DARCO INTERNATIONAL, INC.
    Operator Number
    9001626
    Address
    810 MEMORIAL BLVD., --
    City
    Huntington
    State
    WV
    Postal Code
    25701
    Country
    US

    Products

    Device Name Product Code
    Splint, Extremity, Non-Inflatable, External, Non-Sterile NOC

    Proprietary Names

    Body Armor PFA Walker BODY ARMOR STIRRUP WALKER BODY ARMOR WALKER II COMPONENT KIT ANT AFO TOE ALIGNMENT SPLINT BODY ARMOR PRO TERM ACTIVE ANKLE DORSAL NIGHT SPLINT ANT AFO TABS BODY ARMOR WALKER FX PRO ANTERIOR CARBON FIBER AFO BODY ARMOR NIGHT SPLINT GREAT TOE SPLINT

    Establishment Types

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