Fourier
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…
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.
Who Else Makes It
Concentrated in Shanghai (3), Guangdong (3), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Mateside Medical Devices Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 21 |
| Fourier Intelligence Inc. | Shanghai | Shanghai | Private-label distributor | 6 |
| Shanghai Siyi Intelligent Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
| Shanghai Zdroid Medical Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
| Zhengzhou Angelexo Scientific Co., Ltd. | Zhengzhou | Henan | Manufacturer | 2 |
| Changsha Jinuo Intelligent Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 1 |
| Guangzhou Yikang Medical Equipment Industrial Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 1 |
| Shenzhen Shengye Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 1 |
| Zhuhai Rehaconn Medical Co., Ltd. | Zhuhai | Guangdong | Specification developer | 1 |
Record
| Listed by | Fourier Intelligence Inc., China |
|---|---|
| FDA product code | IKK |
| Device type | System, Isokinetic Testing And Evaluation |
| Device class | Class 2 |
| Regulation | 21 CFR 890.1925 |
| Establishment | Private-label distributor, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-07-16 |
| Record revised | 2026-07-28 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M3D01UR | In distribution | |
| Fourier M2 | In distribution | |
| M3D01UP | In distribution | |
| M3D01UN | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Harmony SHR™ | Harmonic Bionics, Inc. | 12 |
| RPM2 Rx | Medhab, LLC | 8 |
| Trexo Robotics | Trexo Robotics, Inc. | 8 |
| Armeo | Hocoma AG | 7 |
| Lower extremity intelligent feedback training system for children | Guangzhou Yikang Medical Equipment Industrial Co., Ltd. | 6 |
| Steprite | Medhab, LLC | 6 |
| Upper and lower limb active and passive motion assessment training instrument | Guangzhou Yikang Medical Equipment Industrial Co., Ltd. | 4 |
| Bioness Integrated System (BITS)2.0.5 | Bioness Medical, Inc. | 4 |
| Multi-joint isokinetic training and testing system | Guangzhou Yikang Medical Equipment Industrial Co., Ltd. | 3 |
| Actiware | Respironics Inc. | 3 |
| Burt | Barrett Technology, LLC | 2 |
| LifeGlov and Lifehub System | Bioliberty Ltd | 2 |
Showing 12 of 92. All products under System, Isokinetic Testing And Evaluation
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.