FDA.reportPublic FDA data

Kinesis Gait

Primary DI
05391542950010
Brand
Kinesis Gait
Company
KINESIS
Model
2.0.1
Device description
Kinesis Gait consists of a device for assessment of gait and movement through quantitative analysis of gait 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

Product Codes#

Code, Name table
CodeName
PJPFall Prevention Alarm/Sensor Attached Only

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PJPFall Prevention Alarm/Sensor Attached OnlyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391542950010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391542950010053915429500105391542950010

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

Regulatory Flags#

DUNS number
985574496
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391542950027Kinesis Balance2.0.12023-02-22
05391542950003Kinesis QTUG3.2.22023-02-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391542950003Kinesis QTUGKINESISPJP2023-02-22
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
B4841154060"SEAT 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