BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    OmniStim FX2 Portable PENS

    DI: 00858703006092 · Model: 300200A-1 · ACCELERATED CARE PLUS CORP
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OmniStim FX2 Portable PENS
    Primary DI
    00858703006092
    Version / Model
    300200A-1
    Company Name
    ACCELERATED CARE PLUS CORP
    Labeler DUNS
    828331616
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-16
    Public Version
    10
    Public Version Date
    2023-09-26
    Public Version Status
    Update
    Public Device Record Key
    71f8ee1d-f855-4d23-9e79-cd46db21aecb
    Distribution End Date
    2023-08-21

    Device Description

    Powered muscle stimulator

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    IPF Stimulator, Muscle, Powered

    GMDN Terms

    Code Name
    46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

    Identifiers

    Type ID
    Primary 00858703006092

    Customer Contacts

    Phone
    800-350-1100
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K945508 000