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510(k) Data Aggregation

    K Number
    K020284
    Device Name
    BIOTECH MANUAL WHEELCHAIR A2000 SUPER MOTIVE WHEELCHAIR
    Manufacturer
    TAIWAN ARMADA ENTERPRISE CO., LTD.
    Date Cleared
    2002-02-08

    (11 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 A2000 SUPER MOTIVE WHEELCHAIR

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

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

    Device Description

    Not Found

    AI/ML Overview

    This document is a marketing clearance letter from the FDA for a mechanical wheelchair, the "Biotech A2000 Super Motive Wheelchair." It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

    Therefore, I cannot provide the requested information based on the given input, as the document does not contain:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for a test set.
    3. Number or qualifications of experts for ground truth.
    4. Adjudication method for a test set.
    5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
    6. Information about a standalone (algorithm-only) performance study.
    7. The type of ground truth used.
    8. The sample size for a training set.
    9. How ground truth for a training set was established.
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