BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EVERYWAY4ALL

    DI: 04719871184189 · Model: ISTIM V2 · EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EVERYWAY4ALL
    Primary DI
    04719871184189
    Version / Model
    ISTIM V2
    Company Name
    EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
    Labeler DUNS
    657383535
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-04-15
    Public Version
    3
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    0c33cb60-070d-4ff1-b0e3-1aa641867b35

    Device Description

    Electrical Muscel Stimulator (EMS)

    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
    Yes
    MRI Safety
    MR Safe
    Direct Marking Exempt
    No
    PM Exempt
    No
    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
    KPI Stimulator, Electrical, Non-Implantable, For Incontinence

    GMDN Terms

    Code Name
    46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

    Identifiers

    Type ID
    Primary 04719871184189

    Premarket Submissions

    Submission Number Supplement Number
    K213116 000