FDA.report

Kinesis QTUG

Primary DI
05391542950003
Brand
Kinesis QTUG
Company
KINESIS
Model
3.2.2
Device description
QTUG consists of a device for assessment of mobility, falls risk and frailty in older adults through quantitative analysis of movement using body-worn inertial sensors. The device streams data over a Bluetooth interface to an Android tablet device.
Published
2023-02-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
PJPFall Prevention Alarm/Sensor Attached Only

Product Code Classifications

CodeDeviceSpecialtyClass
PJPFall Prevention Alarm/Sensor Attached OnlyGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05391542950003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05391542950003053915429500035391542950003

GMDN Terms

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

Regulatory Flags

DUNS number
985574496
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
05391542950010Kinesis Gait2.0.12023-02-22
05391542950027Kinesis Balance2.0.12023-02-22

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
05391542950010Kinesis GaitKINESISPJP2023-02-22
B48411600710WIRELESS BED MONITOR, FALL FIGHTER, INOVONICS, PRINTEDCrest Healthcare SupplyPJP2020-09-29
B4841160020Wireless Bed Monitor, InovonicsCrest Healthcare SupplyPJP2018-07-18
B4841160040BED PAD,FALL FIGHTER,1/4 RECPTCrest Healthcare SupplyPJP2018-07-18
B4841160050FALL FIGHTER,CHAIR PAD,1/4Crest Healthcare SupplyPJP2018-07-18
B4841144480MONITOR, CHAIR, FALL FIGHTER, W/CLIPCrest Healthcare SupplyPJP2017-08-31
B4841144490MONITOR, BED, FALL FIGHTER, W/CLIPCrest Healthcare SupplyPJP2017-08-31
B4841144500PAD,CHAIR,FALLFIGHTER,1YRCrest Healthcare SupplyPJP2017-08-31
B4841144510PAD,BED,FALLFIGHTER,1YRCrest Healthcare SupplyPJP2017-08-31
B4841145030PAD,CHAIR,FALLFIGHTER,60 DAYCrest Healthcare SupplyPJP2017-08-31
B4841145040PAD,BED,FALLFIGHTER,60 DAYCrest Healthcare SupplyPJP2017-08-31
B4841148510PAD,BED,VIG,1 YRCrest Healthcare SupplyPJP2017-08-31
B4841148520PAD,CHAIR,VIG,1 YRCrest Healthcare SupplyPJP2017-08-31
B4841153830MAT,FLOOR,FALL FIGHTER,GREYCrest Healthcare SupplyPJP2017-08-31
B4841153970MONITOR, INFRARED, FALL FIGHTERCrest Healthcare SupplyPJP2017-08-31
B4841154060SEAT BELT ALARM, FALL FIGHTER, MEDIUM, 38" - 48"Crest Healthcare SupplyPJP2017-08-31
B4841154140SEAT BELT ALARM,FALL FIGHTER, LARGECrest Healthcare SupplyPJP2017-08-31
B4846711360PAD,BED,HD5, 1 YR, 10 PKCrest Healthcare SupplyPJP2017-08-31
B4846711540PAD,CHAIR,HDS,60 DAY,10PKCrest Healthcare SupplyPJP2017-08-31
B4846711580PAD,BED,HDS,60 DAY,10 PKCrest Healthcare SupplyPJP2017-08-31
B4846711750PAD,CHAIR,HDS,1 YR,10PKCrest Healthcare SupplyPJP2017-08-31
B4841139450CHAIR,SENTRY DELUXE MONITOR Crest Healthcare SupplyPJP2017-07-28
B4841139460CHAIR,SENTRY DELUXE MONITORCrest Healthcare SupplyPJP2017-07-28