BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    STEPRITE

    DI: 00850023296160 · Model: 7 Size (3) · MEDHAB, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    STEPRITE
    Primary DI
    00850023296160
    Version / Model
    7 Size (3)
    Catalog Number
    Shoe insole size 3 (women 13.0 to 15.0) (men 11.0 to 12.50)
    Company Name
    MEDHAB, LLC
    Labeler DUNS
    107660874
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-23
    Public Version
    1
    Public Version Date
    2020-10-01
    Public Version Status
    New
    Public Device Record Key
    0c5e8732-bc70-4ac9-8847-26f26f27cd8b

    Device Description

    Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in-clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.

    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
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IKK System, Isokinetic Testing And Evaluation

    GMDN Terms

    Code Name
    61782 Pressure monitoring insole

    Identifiers

    Type ID
    Primary 00850023296160