Identity
- Trade Name
- ®Fourier FDA UDI
- Generic Name
- Virtual-display rehabilitation system, powered-support, upper-limb FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- Fourier M2 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972204540016 FDA UDI
- FDA Product Code
- IKK FDA UDI
- GMDN Term
- Virtual-display rehabilitation system, powered-support, upper-limb FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.1925 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Virtual-display rehabilitation system, powered-support, upper-limb
®Fourier by Shanghai Fourier Intelligence Co., LTD — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Shanghai Fourier Intelligence Co., LTD
Sources (1)
- FDA UDI 5d1a2a4a-ea09-425f-bf5a-ae23d485ff32 33 fields · synced Jun 6, 2026