BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Malleo Immobil Air Walker, low

    Reg #: 9616494 · FEI: 3003117657 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    31
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH
    Registration Number
    9616494
    FEI Number
    3003117657
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Max-Naeder-Strasse 15
    City
    DUDERSTADT Lower Saxony
    Country
    DE

    Owner / Operator

    Firm Name
    Ottobock SE & Co. KGaA
    Operator Number
    8010097
    Address
    Max-Naeder-Strasse 15
    City
    Duderstadt
    State
    Lower Saxony
    Postal Code
    37115
    Country
    DE

    US Agent

    Business Name
    Otto Bock HealthCare LP
    Contact Name
    Caleb Beck
    Address
    3820 West Great Lakes Drive
    City
    Salt Lake City
    State
    UT
    ZIP
    84120
    Country
    US
    Email
    [email protected]
    Phone
    801 9746647

    Products

    Device Name Product Code
    Orthosis, Limb Brace IQI

    Proprietary Names

    Malleo Immobil Air Walker, low Ankle Foot Orthosis Manu Comfort Stainless Steel Elbow Joint Bar with Gable Lock Wristoform wrist support Epiflex Hallux Valgus ComfortT Manu 3D Pollex Epi Forsa Plus Ankle Joint for Children Manu Comfort Stable Double Act. Ankle Jt. Child Acro ComforT ORTHOVALLEY Supramalleolar Orthosis Manu 3D ORTHOVALLEY AFO articulated Manu 3D Basis Epi Sensa Shoulder Support Hallux Valgus Combo ComfortT Correction adapter set Thumboform Long ORTHOVALLEY AFO Solid Ankle Stainless Steel Elbow Joint Bars Syst. Positioning Joint Foot Plates Ankle Joint -Stainl.Steel- Malleo Immobil Air Walker, high Omo Neurexa Plus Stainless Steel Elbow Joint Bar without Lock ORTHOVALLEY AFO Night Splint

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device