FDA.reportPublic FDA data

G-SENSOR

Primary DI
B179GSN2
Brand
G-SENSOR
Company
BTS SPA
Model
2
Catalog number
BTSGSN2
Device description
BTS G-SENSOR 2 is a wireless system consisting of an inertial sensor composed by a tri-axial accelerometer, a magnetic sensor, and a tri-axial gyroscope, that worn by the patient allows a functional gait analysis.
Published
2016-07-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HCCDevice, Biofeedback

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B179GSN21PackageHIBCC1In Commercial Distribution
B179GSN2PrimaryHIBCC0

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
428484518
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B179SEVBUN050SMARTDX EVO5SEVBUN052024-12-27
B179SEVBUN090SMARTDX EVO9SEVBUN092024-12-27
B179SEVBUN260SMARTDX EVO26SEVBUN262024-12-27
B179SEVBUN020SMARTDX EVO2SEVBUN022024-12-20
B179SDXEVO1SMARTDX EVOBTSNET82023-09-06
B179FE3FREEEMG300BTSFE32016-07-06
B179FR1FREEEMG1000BTSEMB1BM2016-07-06
B179THN2TEETHAN2.0BTSEMB1BM2017-09-26
B179TMJTMJOINT1.0BTSEMB1BM2017-02-12
B179OMNOMNIsEMG1.0BTSEMB1BM2017-02-12
B179BAIO1baiobit12020-12-14
B179BAIO11baiobit12020-12-14
B179SDXSMARTDXBTSSDX2017-02-12
B179THN1TEETHAN2.0BTSEMB1BM2017-09-26
B179FE31FREEEMG300BTSFE32016-07-06
B179FR11FREEEMG1000BTSEMB1BM2016-07-06
B179P6KP60006000BTSP6K2017-02-12
B179TMJ1TMJOINT1.0BTSEMB1BM2017-02-12

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