BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TENSAMAX PRO+

    DI: 08800092099010 · Model: 200C · Daeyang Medical Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TENSAMAX PRO+
    Primary DI
    08800092099010
    Version / Model
    200C
    Company Name
    Daeyang Medical Co., Ltd.
    Labeler DUNS
    688463749
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-06-20
    Public Version
    1
    Public Version Date
    2025-06-30
    Public Version Status
    New
    Public Device Record Key
    21b06a45-ca50-41fa-922d-5751dc94197f

    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
    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
    PBX Massager, Vacuum, Radio Frequency Induced Heat

    GMDN Terms

    Code Name
    61186 Multi-modality physical therapy system, professional-use

    Identifiers

    Type ID
    Primary 08800092099010

    Premarket Submissions

    Submission Number Supplement Number
    K214090 000