BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Therapy Light

    DI: 06977863220163 · Model: BIOMAXPRO GRANDE · E.SHINE LIGHTING CO., LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Therapy Light
    Primary DI
    06977863220163
    Version / Model
    BIOMAXPRO GRANDE
    Company Name
    E.SHINE LIGHTING CO., LIMITED
    Labeler DUNS
    547460611
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-03-02
    Public Version
    1
    Public Version Date
    2026-03-10
    Public Version Status
    New
    Public Device Record Key
    549bd9ed-b9fb-4991-a24d-fda90609f21f

    Device Description

    This is a Class II infrared therapeutic heating lamp (Product Code ILY, 21 CFR 890.5500) intended for localized heat therapy to relieve muscle pain, joint stiffness, and improve local blood circulation.

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ILY Lamp, Infrared, Therapeutic Heating

    GMDN Terms

    Code Name
    65723 Red/infrared light phototherapy unit

    Identifiers

    Type ID
    Primary 06977863220163