Barron Associates’ VOTA software system for practice of simulated activities of daily living (ADLs) in upper extremity (UE) rehabilitation has received 510(k) Clearance from the FDA as a Class II medical device under Classification Product Code LXJ.
The 510(k) Summary is available online at:
Indications for Use
A software system used with the Microsoft Kinetic 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. Patient assessment, exercise guidance and approval by the medical professional is required prior to use.
VOTA is now being marketed as SaeboVR under an exclusive marketing and distribution agreement with Saebo, Inc. Saebo is currently taking sign-ups for 10-day free trials of the SaeboVR system, which will be available in Summer 2017. For more information, contact Saebo, Inc. (www.saebo.com, 888.284.5433).