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510(k) Data Aggregation

    K Number
    K011701
    Device Name
    BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR
    Manufacturer
    TAIWAN ARMADA ENTERPRISE CO., LTD.
    Date Cleared
    2001-06-22

    (21 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR

    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

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details, expert qualifications, or ground truth establishment. The document is a 510(k) clearance letter from the FDA for a manual wheelchair, indicating substantial equivalence to a predicate device. It does not contain any details about performance studies or clinical trials with the kind of metrics you've requested.

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