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

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

    K Number: K252893 · Decision Mar 27, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    197

    Basic Information

    Device Name
    ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013)
    K Number
    K252893
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5851
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aneuvo
    Date Received
    September 11, 2025
    Decision Date
    March 27, 2026
    Product Code
    SDO
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    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.

    xStep (xStep)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ARC-EX System

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ARC-EX System

    FDA 510(k)
    FDA Class 2 ·Physical Medicine
    View all