LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K251886

    Validate with FDA (Live)

    Device Name
    EmpowerRide NAVIGATOR
    Manufacturer
    Empower Ride, LLC
    Date Cleared
    2026-01-12

    (206 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Type
    Traditional
    Panel
    Physical Medicine
    Age Range
    2 - 12
    Reference & Predicate Devices
    K140416,K171017,K151492
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EmpowerRide NAVIGATOR is a manual wheelchair; it is intended to provide mobility to children with disabilities who are partially or permanently non-ambulatory and limited to a sitting position.

    Device Description

    The EmpowerRide NAVIGATOR is a manual pediatric wheelchair intended to provide mobility to children with disabilities who are partially or permanently non-ambulatory and limited to a seated position.

    It is designed for caregiver propulsion and is suitable for everyday use in indoor and outdoor environments with flat, firm terrain. The device includes modular adaptive seating and postural supports to meet the therapeutic and mobility needs of pediatric users with neuromuscular, developmental, or orthopedic conditions.

    The NAVIGATOR may be used under the supervision of a healthcare provider or selected independently by caregivers for non-complex pediatric mobility needs. The device has been tested and meets the applicable performance and safety requirements of RESNA WC-1:2019 and ISO 7176 standards for manual wheelchairs.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1