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510(k) Data Aggregation

    K Number
    K974376
    Device Name
    JTECH ADJUSTER REFLEX GUN
    Manufacturer
    J-TECH MEDICAL, INC.
    Date Cleared
    1998-02-18

    (90 days)

    Product Code
    LXM
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    JTECH ADJUSTER REFLEX GUN

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

    The JTECH Adjuster Reflex Gun is designed to be used when the practitioner deems manual adjustment not to be effective, possible or desirable. It can be used for stimulating segments of the cervical spine, thoracic spine and lumbar spine as well as the sacrum, ilium and extremities.

    Device Description

    JTECH Adjuster Reflex Gun

    AI/ML Overview

    I'm sorry, I cannot fulfill your request to describe the acceptance criteria and study proving device performance based on the provided text. The document is an FDA 510(k) clearance letter for the "JTECH Adjuster Reflex Gun," indicating it has been found "substantially equivalent" to predicate devices. This type of document does not contain the detailed information you're asking for regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications.

    The letter focuses on regulatory clearance, not on providing the results of a specific performance study against defined acceptance criteria. Therefore, I cannot extract the requested information from the given text.

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