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510(k) Data Aggregation

    K Number
    K240267
    Device Name
    Klaxon (Twist); Klaxon (Twist R)
    Manufacturer
    KLAXON Mobility GmbH
    Date Cleared
    2025-01-10

    (345 days)

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

    KLAXON Mobility GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TWIST and TWIST R are add-on drive accessories for wheelchairs. The TWIST and TWIST R devices are intended to provide auxiliary power to manual wheelchairs to reduce the pushing power needed by their users. TWIST and TWIST R devices are designed to provide support to active wheelchair users who are physically and mentally able to safely control a manual wheelchair in typical situations, including inclines, even manually.
    Device Description
    The TWIST and TWIST R are add-on drive accessories for wheelchairs. The main parts of the drive unit include a drive wheel with a brushless motor and tire, an Electronic Control Unit (ECU), a removable lithium ion battery pack, an On/Off button and indicators, a carrying and release handle, a battery charger, front and rear lights, and locking pins. The controller includes a wireless interface, On/Off button, battery level LEDs, speed selection lever and brake button, integrated Li-ION battery cell, and a USB-C socket. The handlebar unit includes a wireless interface, On/Off button, battery level LEDs, accelerator, brake levers, integrated Li-ION battery cell, and a USB-C socket.
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    K Number
    K222502
    Device Name
    KLICK (VARIANTS: POWER, RACE, MONSTER)
    Manufacturer
    KLAXON Mobility GmbH
    Date Cleared
    2022-12-16

    (120 days)

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

    KLAXON Mobility GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KLICK is not intended for specific clinical use, but as a support to the mobility of active manual wheelchairs' users. It is designed to add auxiliary power to the manual wheelchair, increasing the mobility for the wheelchair's user. Therefore, bearing in mind the operating precautions described in this document, there is no need for professional, technical or aptitude requirements to operate or use a KLICK device. KLICK devices are intended as add-on devices for wheelchairs, thus the intended user is a person with motor disability who needs of the wheelchair support for movement.
    Device Description
    The KLICK 2021 device is a "TRACTION UNIT" (also called DRIVE UNIT or HUB) which is connected to the wheelchair (via a LINK SYSTEM) to provide electric propulsion to the three wheels resultant vehicle. The motor is in the front wheel (traction unit). The handlebar contains all the interfaces with which the user can drive the vehicle. The front castors rise off the ground and a single wheel, in the "traction unit", is used for steering. Klick can be used both with rigid or foldable wheelchairs. The main parts of the drive unit are as follows: - HUB (drive or traction unit): is the aluminium frame with brushless motor, steering set and aluminium fork, for both the steering and the traction functions - Motor: is a brushless unit with 250W nominal power for the Power variant and 1000W power for the Race and Monster variants - Wheel: aluminium rim, 14inch diameter for Power and Race, 20inch for Monster - Removable battery (available in 3 capacity versions: 11.6Ah, 5.8Ah, 2.9Ah) - Handlebar with user interfaces: - i. Throttle - ii. Cruise control, front/reverse selection switch - iii. Electronic brake - iv. Left hand mechanical brake - v. Right hand mechanical brake - vi. Display command for ON/OFF, level selection, on/off lights (optional), on/off usb charger - Display with driving informations, main parameters adjust. - Stand for support the device when disconnected from the vehicle - Battery charger is an external carriable unit (54,6V 2A) supplied by Klaxon-Mobility GmbH. The main parts of the connection system are: - Clamps: are always connected to the wheelchair, assembled by a Klaxon's trained specialist - Crossbeam: is connected to the clamps and supports the connector; the crossbeam is removable for installation on foldable wheelchairs. The connector is adjusted for each application by a Klaxon's trained specialist - Connector: it includes the front hook and connects the HUB to the crossbeam
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