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510(k) Data Aggregation

    K Number
    K242326
    Device Name
    Wave Electrode (AE02-60); Wave Electrode (AE02-50)
    Manufacturer
    BionIT Labs Srl
    Date Cleared
    2025-01-02

    (149 days)

    Product Code
    GXY, IQZ
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    BionIT Labs Srl

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wave Electrode is to be used exclusively for external prosthetic fittings of the upper limbs.
    Device Description
    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 Wave Electrode it is possible to non-invasively detect the electrical signal produced by the residual muscles on the patient's amputated limb (unilateral 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. Wave Electrode is only compatible with the Adam's Hand that, according to the Requlation Number 890.3420, are classified as class I medical device. Wave Electrode is available in two different models: Mod. AE02-50, with notch filter centred on the 50 Hz frequency; Mod. AE02-60, with notch filter centred on the 60 Hz frequency
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