BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    InTENSity at Home TENS Device

    DI: 00092237619599 · Model: E200-6R · COMPASS HEALTH BRANDS CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    InTENSity at Home TENS Device
    Primary DI
    00092237619599
    Version / Model
    E200-6R
    Company Name
    COMPASS HEALTH BRANDS CORP.
    Labeler DUNS
    827221698
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-05-10
    Public Version
    3
    Public Version Date
    2023-09-12
    Public Version Status
    Update
    Public Device Record Key
    cf23c450-9b12-420c-9b3c-1805d3b7f74e

    Device Description

    InTENSity at Home OTC TENS device with 12 preset programs and 100 Intensity levels

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    MR Safe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    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
    46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

    Identifiers

    Type ID
    Package 30092237619590
    Primary 00092237619599
    Package 80092237619595

    Customer Contacts

    Phone
    800-376-7263
    Email
    [email protected]