BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    7E Wellness

    DI: 08908008085321 · Model: Myocalme RC · JOHARI DIGITAL HEALTHCARE LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    7E Wellness
    Primary DI
    08908008085321
    Version / Model
    Myocalme RC
    Company Name
    JOHARI DIGITAL HEALTHCARE LIMITED
    Labeler DUNS
    675938472
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-04-30
    Public Version
    3
    Public Version Date
    2021-02-19
    Public Version Status
    Update
    Public Device Record Key
    f6753cc0-ed2d-49fd-89eb-c202bb14629d

    Device Description

    Cranial Electrotherapy Stimulation (CES)

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    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
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    QJQ Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety

    GMDN Terms

    Code Name
    35995 Transcutaneous electrical stimulation electrode, single-use

    Identifiers

    Type ID
    Primary 08908008085321

    Customer Contacts

    Phone
    888-412-3160
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K090052 000