Duns Number:428484518
Device Description: BTS G-SENSOR 2 is a wireless system consisting of an inertial sensor composed by a tri-axi 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.
Catalog Number
BTSGSN2
Brand Name
G-SENSOR
Version/Model Number
2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HCC
Product Code Name
Device, Biofeedback
Public Device Record Key
647d6b47-eccc-4579-8fc2-576629960f1b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 06, 2016
Package DI Number
B179GSN21
Quantity per Package
1
Contains DI Package
B179GSN2
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
cutomized bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |