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510(k) Data Aggregation

    K Number
    K101611
    Device Name
    RELAY POWER WHEELCHAIR
    Manufacturer
    DALTON INSTRUMENT CORP.
    Date Cleared
    2010-09-29

    (113 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 :

    RELAY POWER WHEELCHAIR

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

    The intended use of the Relay is to provide mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) summary for the Relay powered wheelchair (K101611) and does not contain information about acceptance criteria or a study proving that a device meets such criteria.

    The 510(k) letter from the FDA confirms that the device is substantially equivalent to legally marketed predicate devices. It lists the device name "Relay" and its regulation number and name. However, it does not include details on specific performance metrics, clinical studies, or acceptance criteria typical for product performance evaluations.

    Therefore, I cannot provide the requested information based on the provided text.

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