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510(k) Data Aggregation

    K Number
    K984493
    Device Name
    MAXXIM; MAXXIM HD
    Manufacturer
    MAJOR MOBILITY PRODUCTS, INC.
    Date Cleared
    1999-01-08

    (22 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of the subject device as well as the predicate device empowers physically challenged persons a means of mobility. This includes temporary and permanent conditions in all ages, including but not limited to arthritis, paraplegic, multiple sclerosis, and other debilitating conditions. Our device and the predicate device provide the same function for occupants who are unable to move due to injuries or other medical conditions.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification from the FDA, specifically concerning the substantial equivalence of a medical device (Maxxim; Maxxim HD manual wheelchair). It does not contain information about acceptance criteria or a study proving that the device meets those criteria.

    Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or studies (MRMC or standalone) because such details are not present in the provided text. The document is about regulatory clearance based on substantial equivalence, not a detailed performance study.

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