Teton Fall Detection

Basic Information

• Brand Name: Teton Fall Detection
• Primary DI: 05745001037000
• Version / Model: R1.0
• Company Name: Teton.AI ApS
• Labeler DUNS: 306198002
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-01
• Public Version: 2
• Public Version Date: 2026-02-05
• Public Version Status: Update
• Public Device Record Key: cee98e3c-7a45-4924-8c68-b76a9b37b8ad
• Distribution End Date: 2025-01-31

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

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PJO	Fall Prevention Alarm/Sensor Combination Attached Or Unattached	General Hospital	880.2400	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05745001037000	GS1