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510(k) Data Aggregation

    K Number
    K252893

    Validate with FDA (Live)

    Device Name
    ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013)
    Manufacturer
    Aneuvo
    Date Cleared
    2026-03-27

    (197 days)

    Product Code
    SDO
    Regulation Number
    890.5851
    Type
    Traditional
    Panel
    Physical Medicine
    Age Range
    18 - 75
    Reference & Predicate Devices
    K132422,DEN240014
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ExaStim Stimulation System is indicated for the improvement of hand sensation and strength in individuals between 18 and 75 years old who present with a chronic, non-progressive neurological deficit resulting from an incomplete spinal cord injury, when used in conjunction with functional task practice.

    Device Description

    The ExaStim® Stimulation System is designed to deliver transcutaneous electrical spinal stimulation for therapeutic use in individuals with incomplete spinal cord injury (SCI). The ExaStim Portable Stimulator is a battery-operated medical device composed of specialized electronics and embedded firmware. It emits stimulation according to parameters configured by the ExaStim Programmer by a clinician.

    The ExaStim Stimulation System consists of the components described in Table 1.

    Part NameDescription
    ReCure® Electrode PadNon-invasive 16-channel multi-electrode array
    ExaStim® Portable StimulatorGenerates and delivers controlled electrical stimulation to the spinal cord and dorsal roots via the ReCure® Electrode Pad based on commands from the ExaStim® Programmer
    ReCure® Stimulation CableConnects the ExaStim® Portable Stimulator to the ReCure Electrode Pad
    ExaStim® Return Electrode CableConnects the return electrodes (i.e., PALS Neurostimulation Electrode) to the ExaStim® Portable Stimulator
    ExaStim® ProgrammerBluetooth‡-enabled mobile digital device preloaded with proprietary ExaStim® Programming Software; includes a charging cable.
    ExaStim® Charging CableCharger used to recharge the battery of the ExaStim Portable Stimulator

    In addition to the components listed above, the system requires two PALS‡ Neurostimulation Electrodes manufactured by Axelgaard, as shown in Table 2 which are not included with the system.

    Part NameCatalog NumberDescription
    PALS‡ Neurostimulation Electrode895240Return electrodes
    AI/ML Overview

    N/A

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