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510(k) Data Aggregation

    K Number
    K013307
    Device Name
    OMEGATRAC, MODEL Z105
    Manufacturer
    TEFTEC CORP.
    Date Cleared
    2002-02-08

    (127 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Indications for use for the Model Z105 ΩmegaTrac® Powered Wheelchair base:

    IntegaTract design definitions and functional parameters are indicated for usage for anyone with limited mobility due to weak, amputated or non-functional extremities or improper, unsafe or non-existent gait patterns. Also, due to the specific driving control supplied by the transaxle, persons with spasticity or ataxic movements in their extremity's that are not candidates for other types of mobility without extensive modification may be appropriate for the SmegaTrac® with no modifications.

    This usage would be indicated but not limited to the following types of injury's:

    Spinal Cord Injury (SCI) Head Injury (CHI) Muscular Dystrophy (MD) Cerebral Palsy (CP) Brown Sequard's Syndrome Severe Arthritics (RA) (OA) Multiple Sclerosis Huntington's Corea Traumatic Brain Injury (TBI) Amyotrophic Lateral Sclerosis (ALS) Anoxic Encephalopathy Anoxia

    Guillain-Barre Syndrome Quadriplegia Paraplegia Triplegia Hemiplegia Tetraplegia Proximal Extremity Weakness Cerebral Vascular Accident (CVA or Stroke) Quadriparesis Obesity Parkinson's

    This is not meant to be an all-inclusive list, anyone needing power assistance with their mobility may be an appropriate client for an QmegaTrac® powered wheelchair. This would usually be decided by clinical evaluation of the client's strength, sitting balance, mobility needs, size constraints and driving capability at their local rehab facility.

    Device Description

    Model Z105 Ωmega Trac® Powered Wheelchair

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a powered wheelchair, the Model Z105 Ωmega Trac®. It includes a determination of substantial equivalence to a legally marketed predicate device and the indications for use.

    This document DOES NOT contain the information requested in the prompt regarding acceptance criteria, device performance studies, sample sizes, expert involvement, or ground truth establishment.

    The request asks for details typically found in a clinical study report or a 510(k) submission summary that describes the testing and validation of an AI/ML powered medical device. The provided text is a regulatory clearance letter, not a technical report detailing the device's development and validation.

    Therefore, I cannot fulfill the request based on the provided input.

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