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510(k) Data Aggregation

    K Number
    K251517

    Validate with FDA (Live)

    Device Name
    Encora Pulse
    Manufacturer
    Date Cleared
    2026-02-05

    (265 days)

    Product Code
    Regulation Number
    N/A
    Age Range
    22 - 120
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Encora X1™ is indicated to aid in the relief of hand tremors in the treated limb during stimulation in adults with essential tremor.

    Device Description

    Encora X1™ is a small, wearable stimulator designed to provide essential tremor symptom relief to the treated hand during stimulation. The device is designed to be worn on a patient's wrist and offers two modes of mechanical stimulation ("Continuous" and "Pulsed"). Both stimulation modes are adjusted based on characteristics of a patient's tremor and target the peripheral nerve distributions of the wrist (median, radial, and ulnar). The Encora X1™ system includes three main components: (1) a rechargeable stimulator, (2) a wrist-worn band with linear resonant actuators, and (3) a charging station that recharges the stimulator.

    The stimulator component contains the electronics for delivering personalized stimulation to the patient's wrist. There are three buttons on the stimulator that are used to activate and adjust stimulation. The status indicator light on the stimulator provides information on device state, including battery charge, stimulation mode, and other states.

    To deliver therapy, the stimulator is attached to the wristband, which includes integrated linear resonant actuators placed at appropriate intervals around the inner diameter of the band to target the appropriate anatomical regions of the wrist. To accommodate a broad range of wrist sizes, the band is available in three sizes (small, medium, and large).

    AI/ML Overview

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