FDA.reportPublic FDA data

Qualisys Clinical System

Primary DI
07300009074518
Brand
Qualisys Clinical System
Company
Qualisys AB
Model
1.5.0.408
Device description
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.
Published
2020-09-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXJInteractive Rehabilitation Exercise Devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXJInteractive Rehabilitation Exercise DevicesPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171547000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171547000Qualisys Clinical SystemQualisys AB2018-08-02LXJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07300009074518PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07300009074518073000090745187300009074518

GMDN Terms#

Term, Definition table
TermDefinition
Gait analysis systemAn assembly of mains electricity (AC-powered) devices and instruments intended to be used to study walking or running patterns. The device uses a platform/mat that measures ground reaction forces or relative pressures (e.g., foot pressure mapping), and/or uses cameras to determine knee, ankle, and hip joint movements and to measure forces and torques. It can be used to diagnose problems related to walking or running and to help plan corrective actions.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2246369833support@qualisys.com

Regulatory Flags#

DUNS number
632151952
Device count
1

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199874027012JintronixLudica Health Inc.LXJ2026-04-20
B179SEVBUN050SMARTBTS SPALXJ2024-12-27
B179SEVBUN090SMARTBTS SPALXJ2024-12-27
B179SEVBUN260SMARTBTS SPALXJ2024-12-27
B179SEVBUN020SMARTBTS SPALXJ2024-12-20
B179SDXEVO1SMARTBTS SPALXJ2023-09-06
00627843933236KneeKG systemEmovi IncLXJ2022-03-23
00885556803868ARIASmith & Nephew, Inc.LXJ2021-04-20
00860001498400VERAREFLEXION HEALTH, INC.LXJ2019-06-30
05707480042548Sleepmate / SparepartBody Position BandAmbu A/SLXJ2019-01-10
05707480042661Body Position Sensor - Alice 3Ambu A/SLXJ2019-01-07
05707480042777VIASYS QDC CABLE GREENAmbu A/SLXJ2019-01-07
05707480042807VIASYS QDC CABLE BROWNAmbu A/SLXJ2019-01-07
05707480042272SleepmateAC Body Position Sensor KitAmbu A/SLXJ2019-01-03
05707480042500SleepmateDC Low Impedance KitAmbu A/SLXJ2019-01-03
05707480042555SleepmateAC Body Position SensorAmbu A/SLXJ2019-01-03
05707480042609SleepmateDC Body Position Sensor - ViasysAmbu A/SLXJ2019-01-03
05707480042685SleepmateDC Body Position Sensor - CadwellAmbu A/SLXJ2019-01-03
05707480042715SleepmateBody Position Sensor - Alice 5Ambu A/SLXJ2019-01-03
05707480042838SleepmateBody Position - CadwellAmbu A/SLXJ2019-01-03
05707480043477SleepmateBody Position SensorAmbu A/SLXJ2019-01-03
03760272650019MindMotion™ GONeuroXtherapeutics SALXJ2018-05-28
03760272650002MindMotion PRONeuroXtherapeutics SALXJ2017-08-01
00863090000400SaeboVRVIRTUAL THERAPY SOLUTIONS, LLC.LXJ2017-06-01
B548BONITASYSTEM0VICONVICON MOTION SYSTEMS LIMITEDLXJ2017-04-18
B548VICONTSERIESSYSTEM0VICONVICON MOTION SYSTEMS LIMITEDLXJ2017-04-18
B548VICONVANTAGESYSTEM0VICONVICON MOTION SYSTEMS LIMITEDLXJ2017-04-18
B548VICONVEROSYSTEM0VICONVICON MOTION SYSTEMS LIMITEDLXJ2017-04-18
B179SDXSMARTBTS SPALXJ2017-02-12