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510(k) Data Aggregation

    K Number
    K260453

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-03-12

    (29 days)

    Product Code
    Regulation Number
    882.1320
    Age Range
    12 - 120
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Remote Wave Electrode is to be used exclusively for external prosthetic fittings of the upper limbs.

    Device Description

    Remote Wave Electrode is an active analogue electrode for detecting any surface electromyographic signals, used for controlling prosthetic devices. It is compact and low-power, ensuring an accurate and fast reading of muscle electrical potentials generated voluntarily by the user. It also provides a real-time output signal proportional to the detected muscle activation.

    Through the Remote Wave Electrode it is possible to non-invasively detect the electrical signal produced by the residual muscles on the patient's amputated limb (unilateral or bilateral amputees, starting from a transradial amputation level) and send an electrical signal to the electronic board of the prosthetic hand with a proportional width to the detected contraction.

    Remote Wave Electrode is only compatible with the Adam's Hand Family, including Adam's Hand (medium e small), Adam's Hand Plus and Adam's Hook prosthetic hands that, according to the Regulation Number 890.3420, are classified as class I medical devices.

    Remote Wave Electrode is available in two different models:

    • Mod. AE03-50, with notch filter centred on the 50 Hz frequency;
    • Mod. AE03-60, with notch filter centred on the 60 Hz frequency
    AI/ML Overview

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