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510(k) Data Aggregation
K Number
K230532Device Name
RADx Intraoral Appliance for Snoring and Sleep Apnea
Manufacturer
Date Cleared
2023-07-12
(135 days)
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
Achaemenid LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Intended to reduce or alleviate snoring, mild to moderate Obstructive Sleep Apnea (OSA) while sleeping in adults.
Device Description
The RADx White Night and RADx White Night-p Intraoral Appliance for Snoring and Mild to Moderate Sleep Apnea are removable intraoral devices used for treating snoring and mild to moderate obstructive sleep apnea. It consists of two custom fabricated adjustable rods that fit separately over the upper and lower teeth. The device functions as a mandibular repositioner, maintaining the lower jaw in a forward position during sleep. This mechanical protrusion acts to increase the patient's pharyngeal space, improving their ability to exchange air during sleep. The device is a prescription device customized for each patient and has an adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The device can be adjusted only by the user and / or the dentist in increments of 0.5 mm.
The custom oral appliance is checked for proper and comfortable fit as well as the appropriate initial progressive arm attachment. The dentist will provide the patient with subsequent progressive arms from 1.0 mm up to 5.0mm in 0.5mm increments.
There are 9 different arms each identified with a number for each side of the jaw. The arms are also identified as either "L" for left or "R" for right.
Variants / Configurations
There are two variants of the device.
The RADx White Night has removable progressive arms with the female housing active as the receptacle for the arms.
The RADx White Night-p was designed with the upper housing and arm as one piece. In this version, the fixed upper tray-arm combination are the progressive parts of the entire apparatus.
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K Number
K112126Device Name
GENUINE FIRST AID CPR MASK
Manufacturer
Date Cleared
2011-12-01
(129 days)
Product Code
Regulation Number
868.5870Why did this record match?
Applicant Name (Manufacturer) :
GENUINE FIRST AID LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CPR mask (without oxygen port) is single use designed for mouth to mask ventilation to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques of a non-breathing adult. It is also used as a barrier that will direct expired air from the patient away from the user. This device should only be used by persons who have received adequate training.
Device Description
Genuine First Aid CPR Face Mask without oxygen port, is made up of medical grade PVC and one-way valve of medical grade K-resin. The mask is used for mouth-to-mask breathing. There is a shield between the person who gives respiration and the victim. Single use, CPR mask includes: One-way filter valve PVC mask without oxygen port Elastic Strap Packaged for easy portability and quick access
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K Number
K102299Device Name
CPR FACE MASK
Manufacturer
Date Cleared
2011-03-18
(217 days)
Product Code
Regulation Number
868.5870Why did this record match?
Applicant Name (Manufacturer) :
GENUINE FIRST AID LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Genuine First Aid CPR Face (with oxygen port) is single use designed for mouth to mask ventilation to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques of a non-breathing adult. It is also used as a barrier that will direct expired air from the patient away from the user. This device should only be used by persons who have received adequate training.
Device Description
Genuine First Aid CPR Face Mask and oxygen port, made up of medical grade PVC and one-way valve made up of medical grade K-resin. The mask is used for mouth-to-mask breathing. There is a shield between the person who gives respiration and the victim. Single use. CPR mask includes: One-way filter valve PVC mask with oxygen port Elastic Strap Packaged for easy portability and quick access
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K Number
K041517Device Name
INFUSIONCATH
Manufacturer
Date Cleared
2004-08-05
(59 days)
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
ID LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The InfusionCath is intended for the infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature.
Device Description
The VeinRx InfusionCath is used to temporarily occlude a vessel in the peripheral vasculature and then deliver a predetermined dose of a physician specified fluid proximally along the inner lumen of the vessel. The VeinRx InfusionCath is comprised of a distal occlusion balloon, a variable treatment length catheter body with elution holes, and a proximal trifurcated Luer connection hub. The Trifurcated hub allows connections for to the following three main systems of the device. The Luer Lock connections for balloon inflation, infusion valve operation and fluid infusion. The device is provided sterile and for single patient use.
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