SaeboVR

Basic Information

• Brand Name: SaeboVR
• Primary DI: 00863090000400
• Version / Model: SaeboVR-1
• Company Name: VIRTUAL THERAPY SOLUTIONS, LLC.
• Labeler DUNS: 080654574
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-01
• Public Version: 3
• Public Version Date: 2021-06-08
• Public Version Status: Update
• Public Device Record Key: 7f8f8192-d2d0-4f8c-b24d-526227597301

Device Description

A software system used with the Microsoft Kinect intended to be used to support repetitive task practice for rehabilitation of adults under supervision of a medical professional in a clinical or home setting. The system includes simulated activities of daily living (ADLs) for the upper extremity with audiovisual feedback & graphic movement representations for patients as well as patient performance metrics for the medical professional.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
LXJ	System, Optical Position/Movement Recording	Physical Medicine	890.5360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60925	Virtual-display rehabilitation system, non-supportive, clinical	An assembly of devices intended to be used in a clinical setting to provide non-gravity-compensating rehabilitation therapy for neuromuscular/musculoskeletal conditions affecting the back/trunk/limbs (e.g., impaired limb function) through patient interaction with a videogame-like display prompting repeated motion of a body part (e.g., arm, hand, leg) for functional improvement; it may also provide performance feedback. It does not provide weight support and is based on motion-sensing devices [e.g., battery-powered patient-worn infrared (IR) glove, motion tracking heel pad, movement tracking camera, software] that communicate wirelessly to provide a virtual-display interface.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00863090000400	GS1