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510(k) Data Aggregation

    K Number
    K012846
    Device Name
    ZIPPY, MODEL I88WA
    Manufacturer
    PILLAR TECHNOLOGY, INC.
    Date Cleared
    2001-11-20

    (89 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To provide an optional means of mobility for physically challenged people.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the "Zippy" powered wheelchair. It is a regulatory document and does not contain information about acceptance criteria or a study proving device performance as it would be presented for an AI/ML-based medical device.

    Therefore, I cannot extract the requested information regarding acceptance criteria and device performance studies from this document. The document primarily focuses on:

    • Regulatory Clearance: Affirming that the device meets the substantial equivalence requirements for market entry.
    • Device Classification: Assigning a regulatory class (Class II) and product code (ITI).
    • General Controls: Reminding the manufacturer of ongoing regulatory responsibilities.
    • Indications for Use: Stating the intended purpose of the device (to provide an optional means of mobility for physically challenged people).
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