AccessGUDID - DEVICE: Vector Gait and Safety System (00810188050014)

GUDID

Device Identifier (DI) Information

Brand Name: Vector Gait and Safety System
Version or Model: VEC-1000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Bioness Medical, Inc.

Primary DI Number: 00810188050014
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119378513 *Terms of Use
Previous DI: 00815962020269

Device Description: Vector Gait and Safety System, Elite Model

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?
58875	Gait rehabilitation frame, electric	An electrically-powered, body-weight unloading, gait rehabilitation device designed to assist a patient with a walking/balance disability (neurogenic, muscular, or osseous in origin) regain lost motor function, by enabling them to hang in a dedicated harness in a vertical position and exercise (e.g., walk over the ground or moving surface of an elliptical/treadmill, climb stairs, perform sit-to-stand movements). It consists of a ceiling- or wall-mounted beam, or floor-standing frame with a motorized attachment assembly connected to the harness which supports the body weight. It is intended to be used in a clinical setting under professional supervision.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BXB	Exerciser, Powered

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
Storage Environment Temperature: between 15 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8313eb7d-2827-4de7-9b04-c4bdb45fa5c7
Public Version Date: July 28, 2025
Public Version Number: 1
DI Record Publish Date: July 18, 2025