Shanghai Fourier Intelligence Co., LTD

Address:Room 203,204,205,206,Building 8, No.2388 Xiupu Road,Shanghai,CN

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Isokinetic Testing And Evaluation (IKK) (1)

Premarket Exempt

Yes

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®Fourier - 06972204540016 Catalog Number :

Device Description : Fourier M2/Fourier M2 Kids based on force feedback and other core technologies, 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.

Device Class : 2

Duns Number: 544517818

Premarket Exempt : Yes

Product Code : IKK

Prescription Use : Yes

Device Count : 1

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