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510(k) Data Aggregation

    K Number
    K150308
    Device Name
    Palm TENS
    Manufacturer
    HEAT IN A CLICK LLC
    Date Cleared
    2015-10-20

    (253 days)

    Product Code
    NUH
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Palm TENS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Palm TENS is intended to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "Palm TENS." This document grants market clearance based on substantial equivalence to a predicate device. It addresses regulatory matters but does not contain any information regarding acceptance criteria, device performance studies, or clinical trial data.

    Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details, sample sizes, expert involvement, or ground truth, as none of that information is present in the provided FDA letter. The letter is a regulatory approval, not a scientific study report.

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