BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    ARC-EX System

    K Number: DEN240014 · Decision Dec 19, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    266

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    Basic Information

    Device Name
    ARC-EX System
    K Number
    DEN240014
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    890.5851
    Medical Specialty
    Physical Medicine
    Decision
    Unknown
    Applicant
    Onward Medical, Inc.
    Date Received
    March 28, 2024
    Decision Date
    December 19, 2024
    Product Code
    SDO
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SDO Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (SDO), ordered by most recent decision date.

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    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013)

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    FDA Class 2 ·Physical Medicine

    ARC-EX System

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    Other Clearances by Onward Medical, Inc.

    K Number Device Name
    K251821 ARC-EX System