BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Home Care

    DI: 04719873683215 · Model: HT 326L · HOME CARE TECHNOLOGY CO., LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Home Care
    Primary DI
    04719873683215
    Version / Model
    HT 326L
    Company Name
    HOME CARE TECHNOLOGY CO., LTD.
    Labeler DUNS
    658105861
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-12-31
    Public Version
    8
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    dca110e3-57cf-4a18-aee5-6938a635ec75

    Device Description

    EMS (Electronic Muscle Stimulator)

    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
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    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
    IPF Stimulator, Muscle, Powered

    GMDN Terms

    Code Name
    46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

    Identifiers

    Type ID
    Primary 04719873683215

    Premarket Submissions

    Submission Number Supplement Number
    K023001 000