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510(k) Data Aggregation

    K Number
    K033829
    Device Name
    BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM, MODEL CRE-2100
    Manufacturer
    BRUNO INDEPENDENT LIVING AIDS, INC.
    Date Cleared
    2003-12-29

    (20 days)

    Product Code
    ILK
    Regulation Number
    890.5150
    Type
    Special
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM, MODEL CRE-2100

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

    The Bruno Electra-Ride™ III Stairway Elevator System, Model CRE-2100, is a Powered Patient Transport, also commonly known as a Stairway Chairlift, or Stairlift. It is a Powered Patient Transport, and is intended for medical purposes to assist transfers of patients, or mobility-impaired persons, up and down flights of stairs.

    Device Description

    Bruno Electra-Ride™ III Stairway Elevator System

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "Bruno Electra-Ride III Stairway Elevator System". It does not contain information about acceptance criteria or specific study data to prove the device meets performance criteria.

    Therefore, I cannot extract the requested information. This type of FDA clearance letter focuses on establishing substantial equivalence to a legally marketed predicate device, not on presenting detailed performance data from a specific study against predefined acceptance criteria.

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