BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Accu-O-Matic

    DI: 00628235150057 · Model: Sp series · ETD Electro-Therapeutic Devices Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Accu-O-Matic
    Primary DI
    00628235150057
    Version / Model
    Sp series
    Catalog Number
    ET-0100
    Company Name
    ETD Electro-Therapeutic Devices Inc
    Labeler DUNS
    253501613
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-09-06
    Public Version
    5
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    ff9851c8-e059-4505-b03a-5c66c0f7e73a

    Device Description

    Advance Transcutaneous Electrical Nerve Stimulator

    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
    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
    GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

    GMDN Terms

    Code Name
    46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

    Identifiers

    Type ID
    Primary 00628235150057

    Customer Contacts

    Phone
    9054758344
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K841427 000