BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ComfyHealth

    DI: 04719879640243 · Model: KE92 · Comfy Health Group Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    ComfyHealth
    Primary DI
    04719879640243
    Version / Model
    KE92
    Company Name
    Comfy Health Group Co., Ltd.
    Labeler DUNS
    658202517
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-09-30
    Public Version
    3
    Public Version Date
    2025-07-09
    Public Version Status
    Update
    Public Device Record Key
    472c1ce6-83e3-4cba-9c9f-3c70d4f74524

    Device Description

    BRACOO KE92 Knee Fulcrum Sleeve Breathable & 4-way Stretch Lightgrey S-Size Pair

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ITQ Joint, Knee, External Brace

    GMDN Terms

    Code Name
    66085 Multiple-joint lower limb orthosis

    Identifiers

    Type ID
    Primary 04719879640243