BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    P6000

    DI: B179P6K · Model: 6000 · BTS SPA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    P6000
    Primary DI
    B179P6K
    Version / Model
    6000
    Catalog Number
    BTSP6K
    Company Name
    BTS SPA
    Labeler DUNS
    428484518
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-02-12
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    464b9a35-b4c5-4293-aaa8-654603c176a7

    Device Description

    BTS P-6000 is a force platform, which measures ground reaction forces throughout its surface, allowing a deep analysis of a subject’s static postural condition and dynamic postural condition.

    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
    Yes
    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
    KHX Platform, Force-Measuring

    GMDN Terms

    Code Name
    35757 Gait analysis system

    Identifiers

    Type ID
    Primary B179P6K