BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Intimina KegelSmart 2 Rechargeable

    DI: 07350075029219 · Model: 9219 · Leloi AB
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Intimina KegelSmart 2 Rechargeable
    Primary DI
    07350075029219
    Version / Model
    9219
    Company Name
    Leloi AB
    Labeler DUNS
    508701849
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-26
    Public Version
    1
    Public Version Date
    2023-07-04
    Public Version Status
    New
    Public Device Record Key
    84d73686-fd48-4b9f-88ca-c91cdb136915

    Device Description

    The Intimina KegelSmart 2 is a pelvic floor muscle exercise device that provides biofeedback and exercise guidance. Each time the device is used it registers the user's pelvic floor muscle contraction strength and automatically sets a strength level, from 1 to 5, for the following session. Each level has a corresponding exercise routine that is communicated to the user with gentle vibrations.

    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
    HIR Perineometer

    GMDN Terms

    Code Name
    32686 Perineometer

    Identifiers

    Type ID
    Primary 07350075029219