Search Results
Found 2 results
510(k) Data Aggregation
K Number
K250482Device Name
Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue
Manufacturer
Fissiontech LLC
Date Cleared
2025-05-08
(78 days)
Product Code
LRK, LQZ
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
Fissiontech LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Advanced Anti Snoring Device 4.0 is intended to help reduce snoring in people 18 years of age or older.
Device Description
The Advanced Anti Snoring Device 4.0 is designed to reduce snoring by gently repositioning the lower jaw forward, which opens the airway and allows for smoother airflow during sleep. By adjusting the position of the lower jaw, the device helps prevent the throat tissues from collapsing and blocking airflow, which is a common cause of snoring. The 4.0 version is customizable, allowing users to set the lower jaw advancement up to 6mm, providing a personalized fit for maximum comfort and effectiveness. This forward positioning also reduces vibrations in the airway, which are often responsible for the snoring sound.
Ask a Question
K Number
K233850Device Name
Difiney Anti Snoring Device
Manufacturer
Fissiontech LLC
Date Cleared
2024-04-18
(135 days)
Product Code
LRK
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
Fissiontech LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Difiney Anti Snoring Device is intended to help reduce snoring in adults 18 years of age or older.
Device Description
The Difiney Anti Snoring device is an intraoral device that is composed of an upper and lower intraoral trays with a handle that is used during the process of customizing the trays. The Difiney Anti Shoring device repositions the jaw anteriorly relative to the maxilla in order to increase the patient's pharyngeal space to improve the ability to exchange air and decrease air turbulence, a causative factor in snoring.
Ask a Question
Page 1 of 1