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510(k) Data Aggregation

    K Number
    K011846
    Device Name
    BIOTECH POWERED WHEELCHAIR, C650PW
    Manufacturer
    ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY
    Date Cleared
    2002-01-18

    (220 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BIOTECH POWERED WHEELCHAIR, C650PW

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

    The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a "Biotech Powered Wheelchair C650PW". This document pertains to the regulatory approval of a physical medical device (a powered wheelchair), not a software or AI-based medical device.

    Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth, experts, and MRMC studies is not applicable to this document. The concepts of "device performance" in this context refer to the physical functionality, safety, and effectiveness of the wheelchair, which would be evaluated through different types of testing (e.g., mechanical, electrical, clinical trials for mobility) rather than AI model performance metrics like sensitivity, specificity, or AUC.

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