BEUDAMED
    FDA Registration Active 🇮🇸 Iceland

    Rebound Ankle Brace

    Reg #: 3003764610 · FEI: 3003764610 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    51
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    OSSUR H/F
    Registration Number
    3003764610
    FEI Number
    3003764610
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    GRJOTHALS 1-5
    City
    REYKJAVIK
    Country
    IS

    Owner / Operator

    Firm Name
    OSSUR Americas
    Operator Number
    9026971
    Address
    200 Spectrum Center Drive, Suite 700
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US

    US Agent

    Business Name
    Ossur
    Contact Name
    Katla Axelsdottir
    Address
    200 Spectrum Center Drive, Suite 700
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    949 3823833

    Products

    Device Name Product Code
    Joint, Ankle, External Brace ITW

    Proprietary Names

    Rebound Ankle Brace Rebound Air Walker LT AFO Leaf Spring AFO Light Rebound Diabetic Walker Formfit Ankle Formfit Walker Formfit Walker Air Low Top Formfit Ankle with Figure 8 Pediatric Walker Formfit Ankle with SpeedLace Form Fit Equalizer Walker Low Top Formfit Air Walker DH OffLoading Walker Rebound Foot Up Formfit Night Splint Posterior Formfit Walker Low Top Formfit Pro Ankle Formfit Foam Ankle Stirrup Achilles heel wedge Rebound Air Walker Formfit Honeycomb Ankle Stirrup Adhesive Insole for wedge Formfit Ankle Stirrup AirForm Pre-inflated Ankle Stirrup AirForm Inflatable Ankle Stirrup Formfit Air Ankle Stirrup AirForm Night Splint AirForm Universal Inflatable Ankle Stirrup Gel Ankle Stirrup Formfit Gel Ankle Stirrup Exoform Dorsal Night Splint Foot Up Disposable Weather Cover Durable Weather Cover Foam Wedge Hygiene Cover Metal Strut Air Walker Width Extender kit Stability Strap Kit Strap Extension Formfit Night Splint Equalizer Walker Range of Motion Walker Equalizer Air Walker AFO Dynamic GameDay Lace Up Equalizer Air Walker Low Top Equalizer Pre-Inflated Air Walker Low Top Equalizer Pre-Inflated Air Walker Equalizer Walker Low Top

    Establishment Types

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