Search Results
Found 1 results
510(k) Data Aggregation
K Number
K151446Device Name
Recovr Rehabilitation System
Manufacturer
Recovr,Inc
Date Cleared
2015-09-18
(112 days)
Product Code
LXJ
Regulation Number
890.5360Why did this record match?
Applicant Name (Manufacturer) :
Recovr,Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Recovr Rehabilitation System is software for use with the Microsoft Kinect motion tracking system that is indicated to support physical rehabilitation of adults in the clinic and at home via performance of therapist-assigned reach exercises for the upper extremities. Patient assessment, exercise guidance, and approval by the medical professional are required prior to use.
Device Description
The Recovr Rehabilitation System (RRS) is a software system that presents games to facilitate the completion of therapist designed and prescribed upper extremity repetitive reaching exercises and that collects data for the therapist on the user's game play. The system was designed in collaboration with an experienced neurorehabilitation occupational therapist and rehabilitation research team. The RRS is intended for use in the clinic or at home. Patient assessment, exercise guidance, and approval by the medical professional are required prior to use.
The system consists of software, a computer, a primary display monitor, a secondary monitor, and a Microsoft Kinect motion-tracking sensor. Users sit on a bench or stand 6-8 feet away from the primary display monitor. The Kinect sensor is placed along the top or bottom edge of the primary display monitor, and the therapist controls the system from a secondary monitor, mouse, and keyboard off to the side of the primary display monitor. The games are based on a traditional carnival shooting gallery, with targets that pop–up to present reaching tasks. The virtual reality environment incorporates video game principles to engage and motivate users to perform the amount of rehabilitation assigned by the rehabilitation therapist. The system collects data on participant movement and actions throughout each session that allows therapists to track participant performance and improvement across therapy sessions.
The device is not supplied sterile or intended to be sterilized by the operator prior to use, and is not intended for single use.
Ask a Question
Page 1 of 1