BEUDAMED
    Product Code: SDO FDA class 2 21 CFR 890.5851

    Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation

    Physical Medicine

    A transcutaneous electrical spine stimulator to improve skeletal muscle strength and sensation is a physical medicine device that can be programmed to apply electrical current via skin-surface electrodes placed over the spine, intended to improve muscle strength and sensation in patients following neurological deficit, leveraging spinal cord stimulation pathways. It is classified as FDA Class II (510(k) required) under regulation 890.5851 in the Physical Medicine specialty, with product code SDO. The device is not an implant and does not support life-sustaining functions.

    View on FDA
    510(k)s
    4
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    3
    Years Active
    1

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    Basic Information

    Product Code
    SDO
    Device Class
    FDA class 2
    Regulation Number
    890.5851
    Medical Specialty
    Physical Medicine
    Review Panel
    PM
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    A transcutaneous electrical spine stimulator to improve skeletal muscle strength and sensation is a device that can be programmed to apply an electrical current via electrodes on a patient's skin over the spine to improve muscle strength and sensation after neurological deficit.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 4 510(k) clearances via K numbers.

    K Number Device Name
    K253638 xStep (xStep)
    K252893 ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013)
    K251821 ARC-EX System
    DEN240014 ARC-EX System

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.