BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Shoulder Pacemaker device (wireless PC)

    DI: 08051122040919 · Model: SPM01M2 · NCS LAB SRL
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Shoulder Pacemaker device (wireless PC)
    Primary DI
    08051122040919
    Version / Model
    SPM01M2
    Catalog Number
    SPM01M2
    Company Name
    NCS LAB SRL
    Labeler DUNS
    429763668
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-09-01
    Public Version
    3
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    0a860ab7-8bdf-4e89-b72b-be341147a7be

    Device Description

    The configuration is composed of an electrostimulator and other components, useful for recharging, wearing, stimulating and/or controlling it. The SPM01M2 configuration supports IEEE 802.15.4 radio interface. In this case it provides for the exchange of data between the stimulator and a receiver connected to the PC, which then collects the data sent by the device and synchronizes the transmission. The dedicated control software is supplied via an usb receiver.

    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
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IPF Stimulator, Muscle, Powered
    KQX Goniometer, Ac-Powered
    HCC Device, Biofeedback

    GMDN Terms

    Code Name
    46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

    Identifiers

    Type ID
    Primary 08051122040919