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510(k) Data Aggregation
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?
Applicant Name (Manufacturer) :
MECTA Corporation
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
K192834Device Name
MECTA Sigma
Manufacturer
Mecta Corporation
Date Cleared
2020-04-26
(207 days)
Product Code
QGH, OGH
Regulation Number
882.5940Why did this record match?
Applicant Name (Manufacturer) :
Mecta Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MECTA Sigma ECT device is for use in treating catatonia or severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years or older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition.
Device Description
Not Found
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