LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K052711
    Device Name
    EMJOI TENS DEVICE
    Manufacturer
    EMJOI, INC.
    Date Cleared
    2006-06-23

    (267 days)

    Product Code
    GZJ
    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 Emjoi TENS Device is intended for symptomatic relief of chronic intractable pain, posttraumatic and post-surgical pain.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information necessary to answer your request. The document is a 510(k) clearance letter from the FDA for a TENS device, but it does not describe any specific studies, acceptance criteria, or performance data for that device. It focuses on the regulatory aspect of market clearance based on substantial equivalence.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1