BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ManaMed Transducer Fixation Strap

    DI: 00810113682761 · Model: MTFIXSTRAP · Manamed, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    ManaMed Transducer Fixation Strap
    Primary DI
    00810113682761
    Version / Model
    MTFIXSTRAP
    Catalog Number
    MTFIXSTRAP
    Company Name
    Manamed, Inc.
    Labeler DUNS
    084042331
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-09-11
    Public Version
    1
    Public Version Date
    2025-09-19
    Public Version Status
    New
    Public Device Record Key
    6d2cc07e-5c70-4b37-903a-86f66a38e8ee

    Device Description

    The ManaSport+ provides non-invasive therapy of low-intensity pulsed ultrasound for the treatment of selected sub-chronic and chronic medical conditions such as soft tissue injuries, shortened tendons due to past injuries and scar tissues, relief of pain, muscle spasms and joint contractures. ManaSport+ transmits a low-intensity ultrasound signal to the patient’s treatment site through ultrasound gel. The patient will experience little or no sensation while in ultrasound mode. The fixation strap has a hook and loop closure that holds the transducer where treatment is desired.

    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
    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
    IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
    PFW Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat

    GMDN Terms

    Code Name
    35709 Electrode/transducer strap, reusable

    Identifiers

    Type ID
    Primary 00810113682761