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510(k) Data Aggregation
K Number
K242326Device 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
882.1320Why 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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