BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Kinesis Balance

    DI: 05391542950027 · Model: 2.0.1 · KINESIS
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Kinesis Balance
    Primary DI
    05391542950027
    Version / Model
    2.0.1
    Company Name
    KINESIS
    Labeler DUNS
    985574496
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-02-22
    Public Version
    1
    Public Version Date
    2023-03-02
    Public Version Status
    New
    Public Device Record Key
    c6f76fb4-472d-42e8-ad86-f0c0bc24de68

    Device Description

    Kinesis Balance is a smartphone application for assessment of balance and falls risk in older adults. The product is software based and uses simple clinical questionnaires and the sensors embedded in a smartphone to measure balance and assess risk of falls. The application is intended to be used by older adults and their carers in the home.

    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
    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
    JFC System, Pressure Measurement, Intermittent

    GMDN Terms

    Code Name
    43115 Posturography system application software

    Identifiers

    Type ID
    Primary 05391542950027