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510(k) Data Aggregation

    K Number
    K993160
    Device Name
    OMEGA TRAC, MODEL Z100
    Manufacturer
    TEFTEC CORP.
    Date Cleared
    1999-11-18

    (58 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Special
    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 ΩmegaTrac® Powered Wheelchair base:

    ΩmegaTrac® 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 ΩmegaTrac® 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 Scierosis Huntington's Corea Traumatic Brain Injury (TBI) Amyotrophic Lateral Scierosis (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 ΩmegaTrac® 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

    Not Found

    AI/ML Overview

    I am sorry, but based on the text provided, I cannot answer the question regarding the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a powered wheelchair, the OmegaTrac®. It confirms the device is substantially equivalent to a predicate device but does not contain information about specific acceptance criteria or details of a study proving those criteria were met, such as sample sizes, ground truth establishment, or expert qualifications. The document is a regulatory approval letter, not a clinical study report.

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