Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K252813

    Validate with FDA (Live)

    Date Cleared
    2026-03-17

    (194 days)

    Product Code
    Regulation Number
    890.3800
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

    Device Description

    Electrical Scooter, SM4226, is for indoor or outdoor uses, and it is powered by two 12 Ah sealed Lead-acid batteries with an off-board charger and configured with 4 PU solid wheels, 2 anti-tip wheels, a seat, a turning tiller, aluminum alloy main frame and a control panel.

    SM4226 is driven by two PU solid rear wheels (7.48" x 2.16") and steered by two PU solid front wheels (7.48" x 2.16%). The user can control the turning tiller to control the front wheels to steer the scooter's direction. The movement of the scooter is controlled by the rider who operates the throttle lever to drive forward or backward, speed adjustment knob and handles on the turning tiller. Release the throttle lever completely and the electromagnetic brake installed in the motor will be activated automatically, and the scooter will stop. There are two anti-tip wheels to prevent the tipping hazard.

    The maximum weight capacity is 297 lbs. (135 kg). Its maximum forward speed is 4 mph (6.4 km/h), and its maximum safe climbing incline angle is 6 degrees. The cruising range per charge is 6.875 miles (11 km). There is a storage basket affixed to the turning tiller.

    The following surfaces are recommended NOT to operate on:

    • Sand surface
    • Wet or icy surface
    • Road maintenance hole metal cover
    • Avoid going up multiple steps.
    • Avoid using escalators. Use the elevator.
    • Too steep incline over 6 degrees.
    • Obstacle climbing ability over 1.96"/ 50 mm
    • Ground clearance below 1.96"/50 mm
    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1