BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ZONN

    DI: 06975188960023 · Model: HL800-BT · Zonnsmart Science & Technology Co.,Ltd
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ZONN
    Primary DI
    06975188960023
    Version / Model
    HL800-BT
    Company Name
    Zonnsmart Science & Technology Co.,Ltd
    Labeler DUNS
    714639269
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-08-27
    Public Version
    1
    Public Version Date
    2024-09-04
    Public Version Status
    New
    Public Device Record Key
    a192f74a-12a0-4f2c-ab34-b9d4efcfcdb1

    Device Description

    This product is a far-infrared penetration instrument, which mainly provides topical heating of the head to increase tissue temperature, and to adjust head massage mode, promoting scalp tissue relaxation, and temporarily increasing 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
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    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
    Package 06975188961020
    Primary 06975188960023