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510(k) Data Aggregation

    K Number
    K142976
    Device Name
    UltraTENS
    Manufacturer
    Shenzhen Dongdixin Technology Co., Ltd
    Date Cleared
    2015-08-26

    (316 days)

    Product Code
    IMI,GZJ
    Regulation Number
    890.5300
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Therapeutic Ultrasound: 1) Pain relief; 2) Reduction of muscle spasm; 3) Joint contractures: 4) Localized increase in blood flow. Transcutaneous Electrical Nerve Stimulation: 1) Symptomatic relief of chronic intractable pain 2)Post-traumatic pain 3)Post-surgical pain

    Device Description

    Not Found

    AI/ML Overview

    I'm sorry, but your request cannot be fulfilled by analyzing the provided text. The documents you've shared are an FDA 510(k) clearance letter and an "Indications for Use" statement for a medical device called "UltraTENS."

    These documents do not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. They are administrative documents regarding regulatory clearance.

    To answer your questions, I would need a detailed study report or clinical trial summary for the UltraTENS device, which is not present in the provided text.

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