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510(k) Data Aggregation

    K Number
    K251821

    Validate with FDA (Live)

    Device Name
    ARC-EX System
    Manufacturer
    Onward Medical Inc.
    Date Cleared
    2025-11-14

    (154 days)

    Product Code
    SDO
    Regulation Number
    890.5851
    Type
    Traditional
    Panel
    Neurology
    Age Range
    13 - 120
    Reference & Predicate Devices
    K132422,DEN240014
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ARC-EX System is intended to deliver programmed transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic and with take-home exercises in the home to improve hand sensation and strength in individuals between 18 and 75 years old that present with a chronic, non-progressive neurological deficit resulting from an incomplete spinal cord injury (C2-C8 inclusive).

    The ARC-EX System is intended to be operated in medical centers by Rehabilitation Professionals and at home by Patients and Persons Providing Assistance to the Patient as needed.

    Device Description

    The ARC-EX System is a medical device that delivers transcutaneous programmed, Carrier Frequency-enabled electrical spinal cord stimulation (ARC-EX Therapy). The System is intended to be used in conjunction with functional task practice in the clinic and with take-home exercises in the home to improve hand sensation and strength in individuals with cervical spinal cord injury (SCI).

    The stimulation is intended to be delivered transcutaneously and the active electrodes are intended to be placed in direct contact with intact skin, in appropriate locations along or near the spine to elicit desired outcomes. The ARC-EX System is intended to be used in a medical center setting by patients and their rehabilitation professionals, and at home by Patients and Persons providing assistance to the patient as needed.

    The primary components of the ARC-EX System are:

    • ARC-EX Stimulator is an internally powered device equipped with a rechargeable battery. It generates and delivers electrical stimulation to the Electrodes based on commands received from the ARC-EX Programmer.

    • ARC-EX Stimulator Charger is a wired charger used to recharge the Stimulator battery.

    • ARC-EX Splitter Box is used to connect and transmit current from the Stimulator to the Electrodes (via the Extension Cables).

    • ARC-EX Extension Cables are used to connect the Splitter Box to the Electrodes. Two different Extension cable lengths are provided: short Extension Cables (50 cm/19.7 inches long) long Extension Cables (100 cm/39.4 inches long)

    • ARC-EX Programmer is an off-the-shelf tablet with the ARC-EX PRO app or the myARC-EX app pre-installed and can be used by the Rehabilitation Professional and the Patient exchange data with the Stimulator.

    • Programmer Charger (Tablet Charger) is used to recharge the Tablet battery.

    • ARC-EX Case is intended for transportation and storage, in between use, of the ARC-EX System.

    The ARC-EX System is intended to be used with the FDA-cleared Axelgaard PALS electrodes (K132422).

    AI/ML Overview

    N/A

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