AccessGUDID - DEVICE: SMART (B179SEVBUN050)

GUDID

Device Identifier (DI) Information

Brand Name: SMART
Version or Model: DX EVO5
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SEVBUN05
Company Name: BTS SPA

Primary DI Number: B179SEVBUN050
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 428484518 *Terms of Use

Device Description: SMART-DX EVO TVC camera component of SMART that is a System for motion analysis, intended for the recording and analysis of human movement patterns in the. fields of rehabilitation, sports medicine, ergonomics, clinical research.

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):	Yes
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?
17929	Biomechanical function analysis system, motion-tracking	A mains electricity (AC-powered) device assembly designed to track and evaluate the movement of the human body or body segments for the purpose of obtaining graphical visualization and biomechanical analysis of the body (e.g., spinal or joint movements). The device can also be used to determine the extent of ataxia (failure of muscular coordination) and will typically be used in the study of sports/work/rehabilitation related mechanisms/tasks; it is not dedicated to gait analysis alone. It may include various components to achieve its purpose [e.g., markers, sensors, video cameras, image processors, and computers].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXJ	System, Optical Position/Movement Recording

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K131660	000

Device Exempt from Premarket Submission: No 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: 77b588be-e87c-459b-af96-b9e909bf18d6
Public Version Date: January 06, 2025
Public Version Number: 1
DI Record Publish Date: December 27, 2024