AccessGUDID - DEVICE: SaeboVR (00863090000400)

GUDID

Device Identifier (DI) Information

Brand Name: SaeboVR
Version or Model: SaeboVR-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VIRTUAL THERAPY SOLUTIONS, LLC.

Primary DI Number: 00863090000400
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080654574 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXJ	System, Optical Position/Movement Recording

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7f8f8192-d2d0-4f8c-b24d-526227597301
Public Version Date: June 08, 2021
Public Version Number: 3
DI Record Publish Date: June 01, 2017