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510(k) Data Aggregation

    K Number
    K014198
    Device Name
    BIOTECH B990K VIVI WHEELCHAIR
    Manufacturer
    TAIWAN ARMADA ENTERPRISE CO., LTD.
    Date Cleared
    2002-02-01

    (42 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 B990K VIVI WHEELCHAIR

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

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

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a mechanical wheelchair, the "Biotech B990K ViVi Wheelchair." This document focuses on the regulatory approval of a hardware medical device based on substantial equivalence to a predicate device, not on AI/algorithm performance. Therefore, the information requested in the prompt regarding acceptance criteria, study details, ground truth, and comparison to AI performance is not contained within this document. The document primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance requirements.

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