®Fourier
Fourier Intelligence Inc. · Model Fourier M2 · UDI-DI 06972204540016
Description
Fourier M2/Fourier M2 Kids based on force feedback and other core technologies, provides multiple training modes, which meet all assessment and training demands of the patients with upper limb dysfunction from flaccid paralysis phase to recovery stage.Fourier M2/Fourier M2 Kids has therapeutic games that provide real-time trajectory feedback via a monitor, which motivate users to train with more immersion. The training trajectory can be customised by using the ‘teaching mode’ which gives the therapist more flexibility to create the training plan. Fourier M2/Fourier M2 Kids also can evaluate the user’s training outcomes including the movement trajectory, movement velocity, movement torque, range of motion, muscle strength and active-passive ratio.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-05-31 | Trexo Robotics Holdings Inc. | Electrical issues that could potentially render the device non-functional, give off electromagnetic influence to surrounding equipment, and risk of burns when in use. |
| 2020-06-08 | Hocoma AG | The motor controller may fail, which can potentially lead to an error in functionality of the Body Weights Support Rope, which means that the rope can go up or down in an uncontrol |
| 2013-12-03 | MedX Holdings, Inc. | Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing. |
| 2012-05-05 | Interactive Motion Technologies, Inc. | Unsupervised patient could potentially mis-use the device and remove or rotate a protective cover and expose a potential pinch hazard. |
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