BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NeckCare Home

    DI: 05694230564040 · Model: v1 · NeckCare Holding ehf
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NeckCare Home
    Primary DI
    05694230564040
    Version / Model
    v1
    Company Name
    NeckCare Holding ehf
    Labeler DUNS
    500824286
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-03-09
    Public Version
    1
    Public Version Date
    2026-03-17
    Public Version Status
    New
    Public Device Record Key
    db4eddab-557c-4e9b-936d-31ddf22c003a

    Device Description

    The NeckCare Home is used to provide prescribed neck movement exercises and measure, record, analyze, and report head motion during instructed head-neck movements.

    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
    No
    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
    QKC Interactive Rehabilitation Exercise Device, Prescription Use

    GMDN Terms

    Code Name
    47518 Biomechanical function analysis/rehabilitation software

    Identifiers

    Type ID
    Primary 05694230564040