AccessGUDID - DEVICE: BTrackS Balance Plate (00860010129104)

GUDID

Device Identifier (DI) Information

Brand Name: BTrackS Balance Plate
Version or Model: BTRACKS-50
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Balance Tracking Systems Incorporated

Primary DI Number: 00860010129104
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079365006 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
43114	Posturography system platform	A device that is a component of a balance/mobility management system equipped with built-in sensors, transducer and/or force plates that register movement of the patient when he/she adjusts his/her centre of gravity (COG) alignment according to the doctor's instructions, or, the platform provokes destabilizing perturbations and the output of these movements are measured and recorded to the system computer. It is used, e.g., for motor control test (MCT), posture studies, balance, mobility training, and/or sense of equilibrium studies. The patient will stand on this device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KHX	Platform, Force-Measuring

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6380e007-6cce-4a13-b868-aacadc1e42bb
Public Version Date: April 07, 2023
Public Version Number: 1
DI Record Publish Date: March 30, 2023