Identity
- Trade Name
- BURT FDA UDI
- Generic Name
- Virtual-display rehabilitation system, powered-support, upper-limb FDA UDI
- Device Name
- BURT Rehabilitation System is indicated to aid in the rehabilitation and evaluation of upper extremities for patients suffering from neurological or musculoskeletal injuries or conditions. BURT is a robotic system with 3 actuators (DC motors) in the base, a relatively thin “arm” section composed of two links (“inner” and “outer”) connected via a rotating joint (driven by the 3rd actuator via cables), electronics to drive the system, firmware and software that control the system and provide therapeutic activities and games for the patient, and a stand that supports the system. FDA UDI
- Model / Reference
- M1400 FDA UDI
- Description
- BURT Rehabilitation System is indicated to aid in the rehabilitation and evaluation of upper extremities for patients suffering from neurological or musculoskeletal injuries or conditions. BURT is a robotic system with 3 actuators (DC motors) in the base, a relatively thin “arm” section composed of two links (“inner” and “outer”) connected via a rotating joint (driven by the 3rd actuator via cables), electronics to drive the system, firmware and software that control the system and provide therapeutic activities and games for the patient, and a stand that supports the system. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00867504000413 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Virtual-display rehabilitation system, powered-support, upper-limb
Burt by Barrett Technology, Llc — 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
- Barrett Technology, Llc
Sources (1)
- FDA UDI ea140002-d0d6-4dd3-a837-c8cd6caa4f7d 34 fields · synced May 30, 2026