LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K994107
    Device Name
    AMYSYSTEMS PTS50-50 DEGREE POWER TILT SYSTEM FOR MID-WHEEL OR FRONT-WHEEL DRIVE POWER WHEELCHAIRS.
    Manufacturer
    AMYLIOR, INC.
    Date Cleared
    2000-01-13

    (38 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

    The intended use of the device is to provide posterior tilting for positioning and pressure relief in a powered wheelchair.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a power tilt system for wheelchairs. It confirms the device's substantial equivalence to a predicate device and its classification.

    The document does not contain any information about:

    • Acceptance criteria or reported device performance for a study.
    • Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone studies, or ground truth details for any testing.
    • Training set information.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided input.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1