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Found 18 results
510(k) Data Aggregation
K Number
K192474Device Name
VERA
Manufacturer
Reflexion Health, Inc.
Date Cleared
2019-10-10
(30 days)
Product Code
LXJ
Regulation Number
890.5360Why did this record match?
Product Code :
LXJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A software system used with the Microsoft Kinect v2 intended to support the physical rehabilitation of adults in the clinic and at home. The system includes rehabilitation exercises for the upper extremity, trunk, and lower extremity with audiovisual feedback & graphic movement representations for patients as well as videos of the patients performing the exercises which can be remotely accessed by the clinician. Patient assessment, exercise guidance and approval by a medical professional is required prior to use.
Device Description
Not Found
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K Number
K182333Device Name
Vera
Manufacturer
Reflexion Health, Inc.
Date Cleared
2019-04-09
(224 days)
Product Code
LXJ
Regulation Number
890.5360Why did this record match?
Product Code :
LXJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not Found
Device Description
Not Found
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K Number
K180880Device Name
DARI Health
Manufacturer
Scientific Analytics, Inc.
Date Cleared
2019-03-07
(338 days)
Product Code
LXJ
Regulation Number
890.5360Why did this record match?
Product Code :
LXJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DARI Health is a computer and video system used to quantify and graphically display human movement patterns and techniques for uses such as assessment and training of limb or body motion in pre/post rehabilitation evaluation, physical therapy, and the like.
Device Description
DARI Health is a "markerless," three-dimensional human motion capture and analytical software system that uses off-the-shelf video cameras, off-the-shelf computer hardware, off-theshelf motion analysis software, and proprietary DARI Health Software (consisting of DARI Connect, DARI Capture plug-in, DARI Insight Engine, and DARI Rerort Engine) or DARA quantify, and document full-body human kinematics and kinetics during patient movement. Motions are recorded in real-time, using a digital "skeleton" to identify joint center and segment data for the cervical spine, upper extremity, trunk, and lower extremity of the paint. The captured video can be viewed after recording has ended or at some later point. During movement, the DARI Health interfaces with the capture software (off-the-shelf, Captury Live) tracks all segments and joint centers as they move in all planes of more the with resulting output is sent to The DARI Insight Engine processing software-either housed it ally on the computer used for capture or in a security-compliant, cloud-based server-where thered drant can be used to calculate all kinetic data produced during the revor d more one more one Such data is then displayed in different report formats-from large, raw datasets to simple, grahital reports that track key biomechanical metrics. Healthcare providers can access patient biomechanical data remotely through a secure webportal or locally on the computer database application to monitor patient progress and view prior or current motion analyses. There is no direct contact with the patient by the DARI Health system, and no energy is delivered to the subject at any point during the usage of the system.
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K Number
K171547Device Name
Qualisys Clinical System
Manufacturer
Qualisys AB
Date Cleared
2018-08-02
(433 days)
Product Code
LXJ
Regulation Number
890.5360Why did this record match?
Product Code :
LXJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Qualisys Clinical System is a camera and computer system used to quantify and graphically display human movement patterns for adults and children. It is intended to be used for movement analysis in the fields of gait analysis, rehabilitation, sports medicine and ergonomics.
Device Description
The Qualisys Clinical System (QCS) is a camera and computer system used to quantify and graphically display human movement patterns for adults and children. It is intended to be used for movement analysis in the fields of gait analysis, rehabilitation, sports medicine and ergonomics.
In order to achieve this, the QCS utilizes data captured from image sensors (motion capture cameras) to triangulate the 3D-position of one or several reflective markers attached to the patient. This is done by two or more cameras calibrated to provide overlapping field of views from multiple angles. QCS produce data with 3 degrees of freedom for each marker, i.e. positional information. Rotational information (e.g. of a limb) may be retrieved from the relative orientation of three or more markers.
The tracking cameras may record images and identify the position of the markers with a high spatial and temporal resolution to generate high performance motion capture of the markers.
The markers are usually attached directly to the skin. The markers are specially designed to reflect the IR-light flashed from the tracking cameras.
In addition, subsystems may be added to record data in synchronization with the tracking cameras to facilitate the analysis, or for pure documentation purposes. The additional subsystems may be any one of, or a combination of: 1) Ordinary video, 2) EMG data and 3) Force plate data.
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K Number
K173931Device Name
MindMotion(TM) GO
Manufacturer
MindMaze SA
Date Cleared
2018-05-17
(142 days)
Product Code
LXJ
Regulation Number
890.5360Why did this record match?
Product Code :
LXJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MindMotion™ GO is a medical device software used in combination with the Microsoft Kinect v2 and Leap Motion controller that supports the physical rehabilitation of adults in the clinic and at home. The software includes rehabilitation exercises for the upper extremity, trunk, and lower extremity; audio-visual feedback and graphic movement representations for patients; and patient performance metrics for the medical professional. Patient exercise guidance, and approval by the medical professional is required prior to use.
Device Description
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K Number
K172882Device Name
UINCARE HOME
Manufacturer
UINCARE Corp.
Date Cleared
2018-05-10
(231 days)
Product Code
LXJ
Regulation Number
890.5360Why did this record match?
Product Code :
LXJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UINCARE software system used with the Microsoft Kinect is intended to be used to support the physical rehabilitation of adults in the clinic or at home. The system includes rehabilitation exercises for the lower and upper extremities with audio- visual feedback & graphic movement representations for patients as well as remotely accessible patient performance metrics for the medical professional. exercise guidance and approval by the medical professional is required prior to use.
Device Description
The UINCARE HOME software system used with the RGB-D Camera is intended to be used to support the physical rehabilitation of adults in the clinic or at home. The system includes rehabilitation exercises for the lower and upper extremities with audio- visual feedback & graphic movement representations for patients as well as remotely accessible patient performance metrics for the medical professional. Patient assessment, exercise guidance and approval by the medical professional is required prior to use.
The UINCARE HOME software utilizes three off-the-shelf accessories: a motion sensing camera, a monitor and a computer; to provide physical therapists and physicians with a software system to prescribe customized physical therapy plans for patients.
UINCARE HOME software provides medical professionals the tools to record and track movements in threedimensional space in order to identify motion and count repetitions during patient participation with a prescribed exercise. Data derived from motion tracking as well as the patient performance metrics can be reviewed by medical professionals to assess exercise movements and adherence to the prescribed exercise. The UINCARE HOME is a software tool that helps extend that expertise.
The UINCARE HOME software has three separate applications.
- (1) UINCARE Client: Patient Application. This application prompts and monitors patients in the performance of a therapy prescribed by their Clinician, monitors and reports exercise data to the Clinician for analysis, and permits a Patient to communicate with that Clinician.
- (2) UINCARE Manager: Clinician Application. This application allows a Clinician to define and update a patient's personal data, a patient's therapy prescription, to monitor a patient's performance of that therapy, and permits a Clinician to communicate with a patient.
- (3) UINCARE Server: Cloud-based Server. It provides to communicate between the UINCARE Client and UINCARE Manager by the internet as well as to deliver and store the patient information, exercise program information and the result of exercise performed by the patient.
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K Number
K162748Device Name
MindMotionPRO
Manufacturer
MindMaze SA
Date Cleared
2017-04-24
(206 days)
Product Code
LXJ
Regulation Number
890.5360Why did this record match?
Product Code :
LXJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MindMotionPRO is a 3D imaging and display system that interactively displays and tracks upper-extremity rehabilitation exercises for adult patients using a combination of 3D virtual environments and avatars for visual feedback. These rehabilitation exercises are intended to be conducted in a clinical environment and supervised by a medical professional trained in the proper utilization of the MindMotionPRO.
Device Description
MindMotionPRO is a 3D imaging and display system that interactively displays and tracks upper-extremity rehabilitation exercises for adult patients using a combination of 3D virtual environments and avatars for visual feedback.
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K Number
K163245Device Name
Virtual Occupational Therapy Application (VOTA)
Manufacturer
Barron Associates, Inc.
Date Cleared
2017-02-28
(102 days)
Product Code
LXJ
Regulation Number
890.5360Why did this record match?
Product Code :
LXJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A software system used with the Microsoft Kinect intended 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 audio-visual 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.
Device Description
The VOTA software system comprises a VOTA patient-facing and a provider-facing Provider Dashboard. The VOTA patient-facing application supports repetitive task practice exercises for the upper extremity that are consistent with Standard of Care for physical rehabilitation of adults. The software runs on a personal computer under the Windows 8.1 operating system (or later) and uses a Microsoft Xbox One Kinect Sensor (hereafter referred to as Kinect Sensor) to track patient arm movements. These arm movements are translated into equivalent movements of a graphical avatar that represents the patient in a virtual environment. The patient is thus able to practice activities of daily living (ADLs) that involve meaningful tasks and evoke functional movements with graduated levels of difficulty. The activities are organized into a virtual "Road to Recovery" that traverses a series of four islands, each organized around a central theme. There is no physical contact between the patient and the device during exercises, and thus no energy is directed to the patient assessment by a medical professional, and selection of exercise and settings, is required prior to use.
The provider-facing VOTA Provider Dashboard application enables the medical professional to view patient performance metrics and participation history using data produced by the VOTA patient-facing application. The application runs on the same personal computer and operating system as the patientfacing application.
All hardware associated with VOTA are commercial-of-the-shelf, consumer hardware items. The VOTA system ships with the following:
- Microsoft Xbox One Kinect Sensor and Kinect power supply;
- Microsoft Xbox Kinect Adapter for Xbox One ;
- Kinect TV Mount for Xbox One;
- Personal computer (preloaded with VOTA software) and computer power supply;
- Wireless keyboard;
- HDMI cable;
- Getting Started Guide; and
- Third-party Labeling Package
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K Number
K151955Device Name
YuGo System
Manufacturer
BIOGAMING LTD.
Date Cleared
2016-02-05
(205 days)
Product Code
LXJ
Regulation Number
890.5360Why did this record match?
Product Code :
LXJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A software system used with the Microsoft Kinect intended to support the physical rehabilitation of adults in the clinic/ at home. The system includes rehabilitation exercises for the lower and upper extremities with audio- visual feedback & graphic movement representations for patients as well as remotely accessible patient performance metrics for the medical professional. Patient assessment, exercise guidance and approval by the medical professional is required prior to use.
Device Description
The YuGO device, developed by Biogaming Ltd. is a virtual reality platform used with the Microsoft Kinect motion sensing technology, which provides exercise programs for the body's lower and upper extremities. It allows physical therapists to define professional, supervised, and personalized exercise programs via video games or a virtual trainer.
The system was designed to serve a number of purposes:
Allowing the treating clinician a direct access to the training program performed at the patients' home. by determining the allowed movements. extent and difficulty levels of the training protocol.
Encourage physical therapy home-training through the use of camera- sensors, visualizing and promoting body movements using a game displayed on screen.
Collecting movement and performance related data from the home- user; analyzing it and instantly preparing a report on a designated website, to allow treating clinicians (the patients' Physical Therapist or a Physician) access to a "performance report", in order to monitor, adjust and otherwise modify the training protocol to suit the needs of the patient in his rehabilitation process.
The system includes three (3) main functions: Clinician Dashboard, Patient Interface and Reporting System. Using the Microsoft Kinect for Windows to track motion, the YuGo Patient Interface records performance metrics providing them to qualified medical professionals via the Clinician Dashboard, in the Reporting system. Medical professionals can monitor patients performance, assign or modify rehabilitation exercises in Patient Interface for their patients through the Clinician Dashboard allowing for patients to perform their prescribed rehabilitation program even from the comfort of their home.
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K Number
K150462Device Name
Vera
Manufacturer
Reflexion Health, Inc.
Date Cleared
2015-10-30
(249 days)
Product Code
LXJ
Regulation Number
890.5360Why did this record match?
Product Code :
LXJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A software system used with the Microsoft Kinect v2 intended to support the physical rehabilitation of adults in the clinic and at home. The system includes rehabilitation exercises for the lower extremity with audio-visual feedback & graphic movement representations for patients as well as remotely accessible patient performance video. Patient assessment, exercise guidance and approval by a medical professional is required prior to use.
Device Description
The Vera™ software utilizes three off-the-shelf accessories: a motion sensing camera, a monitor and a computer; to provide physical therapists and physicians with a software system to prescribe customized physical therapy plans for patients. Vera™ software provides medical professionals the tools to record video and track movements in three-dimensional space in order to identify motion and count repetitions during patient participation with a prescribed exercise. Data derived from motion tracking as well as the recorded video can be reviewed by medical professionals to assess exercise movements and adherence to the prescribed exercise; Vera™ is a software tool that helps extend that expertise. The Vera™ software has three separate applications: Patient Application, Clinician Application, and Server Application.
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