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510(k) Data Aggregation

    K Number
    K143383
    Device Name
    Q6 Edge EM
    Manufacturer
    Pride Mobility Product Corporation
    Date Cleared
    2015-07-23

    (240 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pride Mobility Product Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Pride Mobility Products Corporation Q6 Edge EM is to provide mobility to persons limited to a seated position that have the capability of operating a Powered Wheelchair.
    Device Description
    The Q6 Edge EM is a Powered Wheelchair having a digital controller, electrical system, motors, encoders, batteries, seating, actuator driven stability system, and frame. The Q6 Edge EM is equipped with electronic, regenerative disc brakes, off-board battery charger, removable 12 Volt U1 batteries, and front and rear caster wheels. The Q6 Edge EM is designed with ultimate safety, stability, and performance in mind. The Powered Wheelchair is designed for, but not limited to Pride Mobility Products Corporation, providers/retailers and their consumers. The Q6 Edge EM will incorporate all of the same features as current devices with elevation, but will utilize a secondary power actuator assembly in the base to lock the casters for additional stability. The actuator will be controlled through the current control system. The addition of the actuator assembly is the reason for this change. The Q6 Edge EM utilizes a digital controller with a Class 1 Bluetooth®. The actual power output of the Bluetooth® device is 10 dBm (which is 10 mW) maximum output power at 50 Ohm impedance, and the maximum range is 40 m. The specific RF wireless technology type for this Bluetooth® is a Co-existence with IEEE 802.11 (AWMA, AFH). The Bluetooth® has 128-bit encryption security. The Bluetooth® allows clients to connect to a computer, smartphone, and tablet. The Bluetooth® is not active during driving or seating operation.
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