BURT

Basic Information

• Brand Name: BURT
• Primary DI: 00867504000413
• Version / Model: M1400
• Company Name: BARRETT TECHNOLOGY, LLC
• Labeler DUNS: 080108367
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-15
• Public Version: 2
• Public Version Date: 2022-08-05
• Public Version Status: Update
• Public Device Record Key: ea140002-d0d6-4dd3-a837-c8cd6caa4f7d

Device 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IKK	System, Isokinetic Testing And Evaluation	Physical Medicine	890.1925	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47517	Virtual-display rehabilitation system, powered-support, upper-limb	An assembly of devices intended to be used in a clinical setting to provide gravity-compensating rehabilitation therapy for neuromuscular/musculoskeletal conditions affecting the upper limbs (e.g., impaired arm function) through patient interaction with a videogame-like display prompting repeated motion of the limb under treatment (e.g., arm, hand, wrist, shoulder) for functional improvement (e.g., reaching, grasping); it may also provide performance feedback and manual/automatic setting adjustments. It consists of a limb support capable of actively assisting the patient’s movements (e.g., powered robotic arm), and a computer/monitor with software.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00867504000413	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]