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510(k) Data Aggregation

    K Number
    K955808
    Device Name
    DYNA T-2000 PHYSICAL THERAPY SYSTEM
    Manufacturer
    THERMIA, INC.
    Date Cleared
    1997-11-03

    (682 days)

    Product Code
    IMB
    Regulation Number
    890.5250
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DYNA T-2000 PHYSICAL THERAPY SYSTEM

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

    Not Found

    Device Description

    DYNA T-2000 Physical Therapy System

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called the DYNA T-2000 Physical Therapy System. It states that the device is substantially equivalent to legally marketed predicate devices.

    However, this letter does not contain the information required to answer your questions about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications. This type of information is typically found in the 510(k) submission itself, often in sections detailing performance data and clinical studies, which are not part of this clearance letter.

    Therefore, I cannot provide the requested details based solely on the provided text.

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