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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?
Applicant Name (Manufacturer) :
NeuroVice, LLC
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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