BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Enso Model 2

    DI: 00195893670284 · Model: 100-365 · Hinge Health, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Enso Model 2
    Primary DI
    00195893670284
    Version / Model
    100-365
    Company Name
    Hinge Health, Inc.
    Labeler DUNS
    080601423
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-05-01
    Public Version
    2
    Public Version Date
    2022-10-26
    Public Version Status
    Update
    Public Device Record Key
    d2a8cdd3-7a5e-4d07-9ce7-5a6b87ad6bbe
    Distribution End Date
    2022-09-30

    Device Description

    Nerve stimulator for pain relief

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

    GMDN Terms

    Code Name
    35372 Analgesic transcutaneous electrical nerve stimulation system

    Identifiers

    Type ID
    Primary 00195893670284

    Customer Contacts

    Phone
    855-902-2777
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K160052 000