SaeboVR

GUDID 00863090000400

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.

VIRTUAL THERAPY SOLUTIONS, LLC.

Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical

• Primary Device ID: 00863090000400
• NIH Device Record Key: 7f8f8192-d2d0-4f8c-b24d-526227597301
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SaeboVR
• Version Model Number: SaeboVR-1
• Company DUNS: 080654574
• Company Name: VIRTUAL THERAPY SOLUTIONS, LLC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863090000400 [Primary]

FDA Product Code

• LXJ: System, Optical Position/Movement Recording

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-06-01