AccessGUDID - DEVICE: Teton Fall Detection (05745001037000)

GUDID

Device Identifier (DI) Information

Brand Name: Teton Fall Detection
Version or Model: R1.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Teton.AI ApS

Primary DI Number: 05745001037000
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 306198002 *Terms of Use

Device Description: Teton's Fall Detection system uses a device equipped with a camera to monitor the room, analyzing live video feeds through AI models that are processed locally. These models interpret human activity within the camera’s field of view and make real-time predictions, specifically detecting falls. At night, infrared lighting is used to enhance visibility, ensuring continuous monitoring. Once a fall is detected, the processed data is securely transmitted to care staff through a dedicated server, enabling timely intervention. The focus of this feature is precision and reliability, ensuring patient safety while minimizing system complexity by concentrating solely on fall detection rather than the broader ecosystem of the Teton One system.

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?
63286	Inpatient motion surveillance software	A software program designed to be used in a healthcare setting to track the movements of an inpatient, typically a patient in a hospital side/isolation room or nursing home, to detect high-risk behaviour (e.g., bedridden patient bed vacation attempt, fall risk) and automatically send alert notifications to healthcare staff via a central monitoring station or nurse call system in response. It is used in conjunction with video surveillance motion sensors/cameras and is intended to analyse patient motion with respect to predetermined motion threshold references.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PJO	Fall Prevention Alarm/Sensor Combination Attached Or Unattached

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: cee98e3c-7a45-4924-8c68-b76a9b37b8ad
Public Version Date: January 09, 2025
Public Version Number: 1
DI Record Publish Date: January 01, 2025