BEUDAMED
    FDA Registration Active 🇺🇸 United States

    925.ERLE-Twin-DELUXE - Edema Reduction Leg Elevator Twin Deluxe

    Reg #: 2321033 · FEI: 3003399881 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    16
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    BONE FOAM INC.
    Registration Number
    2321033
    FEI Number
    3003399881
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    20175 County Road 50
    City
    Corcoran
    State
    MN
    ZIP
    55340
    Country
    US

    Owner / Operator

    Firm Name
    Bone Foam Inc.
    Operator Number
    9046835
    Address
    20175 County Rd 50
    City
    Corcoran
    State
    MN
    Postal Code
    55340
    Country
    US

    Products

    Device Name Product Code
    Orthosis, Limb Brace IQI

    Proprietary Names

    925.ERLE-Twin-DELUXE - Edema Reduction Leg Elevator Twin Deluxe 925.ERLE-P-BX4 - Edema Reduction Leg Elevator Pediatric - Box 4 925.ZDK-Mansfield-BX12 - Zero Degree Knee Disposable - Box of 12 925.ZDK-AveraMarshall-BX12 - Zero Degree Knee Disposable - Box of 12 925.ZDK-BX12 - Zero Degree Knee Disposable - Box of 12 925.ERLEC-L - Edema Reduction Leg Elevator Large - Coated 925.REARLIEF - Rearlief Support Pillow 925.ERLE-HC-BX3 - Edema Reduction Leg Elevator Heel Cut - Box of 3 925.ERLE-R-BX3 - Edema Reduction Leg Elevator Regular - Box of 3 925.ERLE-L-BX3 - Edema Reduction Leg Elevator Large - Box of 3 925.ERLEC-R - Edema Reduction Leg Elevator Regular - Coated 925.ZDKC - Zero Degree Knee Coated 925.ERLE-DELUXE - Edema Reduction Leg Elevator Deluxe 925.KBEX-BX4 - Knee Buddy Extender - Box of 4 925.ZDK-AveraMcKennan-BX12 - Zero Degree Knee Disposable - Box of 12 925.ERLE-Twin - Edema Reduction Leg Elevator Twin

    Establishment Types

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