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510(k) Data Aggregation
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?
Applicant Name (Manufacturer) :
Scientific Analytics, Inc.
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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