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510(k) Data Aggregation

    K Number
    K993919
    Device Name
    DYNATRON 900
    Manufacturer
    DYNATRONICS CORP.
    Date Cleared
    2000-01-03

    (46 days)

    Product Code
    ITH
    Regulation Number
    890.5900
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DYNATRON 900

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

    FOR MEDICAL PURFOSES USE FOIZ ILLATENDED with TRATION ACCESSORIES, such AS IN CONSUNCTION RECTS HAWESSES TO EXERT THERADITIC RULLIN ON THE PATIENTYS, BOD FORES 890,5900 PIMARIC FOR THE LERVICAL - LUMBAR

    Device Description

    Dynatron 900 Traction Unit

    AI/ML Overview

    This document is a 510(k) clearance letter for the Dynatron 900 Traction Unit. It does not contain any information about acceptance criteria, device performance tables, sample sizes, expert qualifications, ground truth establishment, or study designs (MRMC, standalone).

    Therefore, I cannot provide answers to your specific questions based on the provided text. The letter only confirms that the FDA has found the Dynatron 900 Traction Unit to be substantially equivalent to a legally marketed predicate device for its indicated uses.

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