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510(k) Data Aggregation
K Number
K221469Device Name
PATI (Protector Against Tongue Injury)
Manufacturer
NeuroVice, LLC
Date Cleared
2023-02-22
(278 days)
Product Code
JXL
Regulation Number
882.5070Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PATI device is a single-use (disposable) oral protector for use during spontaneous seizures and any circumstances requiring the protection of the teeth, lips, tongue, and buccal mucosa. The PATI is indicated for use with any individual aged 12 or older who suffers from seizures and can be used in a clinical or non-clinical environment.
Device Description
The Protector Against Tongue Injury (PATI) device is a symptom-management, oral device technology that helps to protect against oral injury during seizures, while also allowing fluids to naturally drain or be suctioned. The device will be administered by the patient, an assistant, or medical personnel, (such as hospital staff, EEG technicians, or first responders, including EMTs and paramedics), prior to full onset of a seizure. The device is single use and disposable.
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K Number
K201309Device Name
ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium
Manufacturer
MECTA Corporation
Date Cleared
2021-06-04
(385 days)
Product Code
JXL
Regulation Number
882.5070Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ECT Cotton Bite Block is a single-use (disposable) oral protector for use during seizures induced by electroconvulsive therapy (ECT), to protect the patient's lips, teeth and tongue. It is placed between the back molars, with the tongue medial, and one side of the bite block sticking out of the patient's mouth to keep the mouth open.
Device Description
During the passage of the electrical stimulus during ECT, despite the fact that the patient has been given a systemic muscle relaxant, the masseter muscles contract forcefully, necessitating the use of a bite block or mouth guard. The ECT Cotton Bite Block is intended for single-use only, and is placed between a patient's back molars in order to protect the teeth and tongue during an electroconvulsive therapy (ECT) treatment. Patients who are mentally ill commonly have poor oral hygiene. The placement of the bite block, only on one side of the mouth, allows for any damaged or compromised molars on the opposite side of the mouth to be free from compression. In addition, incisors avoid the risk of being damaged during compression, and the ¾' thick soft cotton provides necessary cushioning for the remaining teeth that are biting down on the cotton roll. One end of the bite block remains outside of the mouth, propping the mouth open for oxygen to be administered, and to ensure that the bite block is staying in place.
Material: The ECT Cotton Bite Block is made of 100% purified medical grade cotton, and is a cylindrical shaped dense cotton roll wrapped in cotton silky yarns.
Sizes: There are two sizes, and size used is determined by the patient's mouth size. The large size is 3/4 inch diameter and 4 inches long, and the medium is ¾ inch diameter and 2 ¾ inches long.
Environment: Electroconvulsive Therapy is administered in a hospital operating room or ECT Suite.
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K Number
K172978Device Name
SurgeoBite
Manufacturer
Surgovations LLC
Date Cleared
2017-12-22
(86 days)
Product Code
JXL
Regulation Number
882.5070Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SurgeoBite® device is single-use (disposable) oral protector for use during seizures induced by electroconvulsive therapy, spontaneous seizures, neuromonitoring stimulation, and any circumstances requiring protection of the teeth, lips, tongue, and buccal mucosa.
Device Description
The SurgeoBite is designed to be an easy to use and safe device for use in the patient's mouth. The shape of the device allows for easy positioning into the mouth and provides a biting surface between the teeth making sure that the tongue and cheeks are not between the biting surfaces. During seizures induced by electroconvulsive therapy, neuromonitoring stimulation, spontaneous seizures, and circumstances requiring protection, the jaw muscles can contract and cause potential damage to the teeth and mouth tissues. By placing the oral protector in the patient's mouth, it will provide protection of the teeth, lips, tongue, and buccal mucosa. The SurgeoBite is sold nonsterile, single use, and is discarded after use.
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K Number
K150518Device Name
Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm
Manufacturer
DUPACO INC.
Date Cleared
2015-06-29
(119 days)
Product Code
JXL, CAE
Regulation Number
882.5070Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Airway with Bite Block and Tongue Depressor is a combined oral airway and bite block that will allow an anesthesia provider to establish a patent airway in an anesthetized patient while simultaneously preventing occlusion of the teeth. It is intended for use during Electroconvulsive Therapy (ECT) procedures or whenever a bite block is required to prevent occlusion of an endotracheal tube.
Device Description
The Airway with Bite Block and Tongue Depressor is a combined oral airway and bite block that will allow an anesthesia provider to establish a patent airway in an anesthetized patient while simultaneously preventing occlusion of the teeth. It is intended for use during ECT procedures and whenever a bite block is required to prevent occlusion of an endotracheal tube.
The Airway with Bite Block and Tongue Depressor is available in two sizes, Medium - 80 mm and Large - 90 mm.
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K Number
K050188Device Name
EPIGUARD
Manufacturer
EPISAFE MEDICAL DEVICES, LTD.
Date Cleared
2005-04-27
(90 days)
Product Code
JXL
Regulation Number
882.5070Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EpiGuard is intended for the prevention of oral soft tissue damage during epileptic tonic-clonic seizures proceeded by an aura.
Device Description
The EpiGuard is a single use oral protective device manufactured from biocompatible silicone. It is provided clean (non-sterile). Besides providing a physical barrier to prevent tongue and cheek damage of the user, the device will maintain an open airway in the mouth cavity and allow the free flow of air and vomit. In addition, the device is griped under the palatals and teeth of the user while also being held in front by the interior surface of the lips. This allows the EpiGuard to be fixed to the necessary position to prevent it from being swallowed.
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