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510(k) Data Aggregation

    K Number
    K241365
    Device Name
    Pixie Pulse (SM9068)
    Manufacturer
    Pixie Cup LLC
    Date Cleared
    2024-08-12

    (90 days)

    Product Code
    NUH,DAT
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Pixie Pulse is designed for symptomatic relief and management of chronic pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, wast, back, neck, upper extremities (arm) and lower (extremities) leg due to strain from exercise or normal household work activities. The Pixie Pulse is also indicated for temporary relief of pain associated with dysmenorthea (menstrual cramps) when used with over-the-counter pain medications.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for the Pixie Pulse (SM9068) Transcutaneous Electrical Nerve Stimulator, outlining its approved indications for use and regulatory compliance. It does not include details on performance studies, sample sizes, ground truth establishment, or expert involvement.

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